Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left double-blind comparative clinical trial
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Protocol summary
This study is a triple-blind randomized clinical trial.
This study is a double-blind randomized clinical trial.
This study is a tripledouble-blind randomized clinical trial.
این مطالعه کارآزمایی بالینی تصادفی سه سویه کور می باشد
این مطالعه کارآزمایی بالینی تصادفی دو سویه کور می باشد
این مطالعه کارآزمایی بالینی تصادفی سهدو سویه کور می باشد
This clinical trial will be conducted in Dr Ali Shariati hospital Alborz university of medical science and Razi hospital Tehran university of medical science. Participants, healthcare providers ,and statistics specialist will be all blinded.
This clinical trial will be conducted in The Center for Research and Training in Skin Diseases and Leprosy, and Razi hospital of Tehran University of medical sciences. Participants and healthcare providers will be blind.
This clinical trial will be conducted in Dr Ali Shariati hospital Alborz university of medical scienceThe Center for Research and Training in Skin Diseases and Leprosy, and Razi hospital of Tehran universityUniversity of medical sciencesciences. Participants, and healthcare providers ,and statistics specialist will be all blindedblind.
محل انجام کارآزمایی بیمارستان دکتر علی شریعتی علوم پزشکی البرز و بیمارستان رازی علوم پزشکی تهران می باشد. در این مطالعه اطلاعات از بیماران،کادر درمان و آماریست مخفی نگاه داشته خواهد شد و تنها یک شخص غیر دخیل در مطالعه از نحوه ی تقسیم بندی اطلاع خواهد داشت.
محل انجام کارآزمایی مرکز آموزش و پژوهش بیماری های پوست و جذام و بیمارستان رازی علوم پزشکی تهران می باشد. در این مطالعه اطلاعات از بیماران و کادر درمان مخفی نگاه داشته خواهد شد و تنها یک شخص غیر دخیل در مطالعه از نحوه ی تقسیم بندی اطلاع خواهد داشت.
محل انجام کارآزمایی بیمارستان دکتر علی شریعتی علوم پزشکی البرزمرکز آموزش و پژوهش بیماری های پوست و جذام و بیمارستان رازی علوم پزشکی تهران می باشد. در این مطالعه اطلاعات از بیماران، و کادر درمان و آماریست مخفی نگاه داشته خواهد شد و تنها یک شخص غیر دخیل در مطالعه از نحوه ی تقسیم بندی اطلاع خواهد داشت.
Individuals aged between 18-50 years old (regardless of gender) diagnosed with mild to moderate facial acne vulgaris (GAGS score ranging from 1 to 30) , and discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention are included in this study. Exclusion criteria are as following: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
Inclusion criteria: individuals aged between 18-50 years old (regardless of gender) diagnosed with mild to moderate facial acne vulgaris (GAGS score ranging from 1 to 30); discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention. Exclusion criteria: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
IndividualsInclusion criteria: individuals aged between 18-50 years old (regardless of gender) diagnosed with mild to moderate facial acne vulgaris (GAGS score ranging from 1 to 30) , and; discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention are included in this study. Exclusion criteria are as following: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
The number of 40 patients participating in this study are considered as 80 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 12 weeks.In the three-month follow-up period, the patients will use identical facial cleansers and sunscreens.
The number of 20 patients participating in this study are considered as 40 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 8 weeks. Through the treatment period and in the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
The number of 4020 patients participating in this study are considered as 8040 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 12 weeks.In8 weeks. Through the threetreatment period and in the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
در مجموع 40 بیمار وارد مطالعه می شوند که به صورت 80 نیمه صورت راست/چپ در نظر گرفته می شوند و به 2 گروه 40 نفره تقسیم می شوند که به صورت تصادفی کرم سیاه دانه یا کرم ترتینونیئن به مدت 12 هفته دریافت می کنند. در دوره ی سه ماهه ی فالوآپ، بیماران از شوینده و ضدآفتاب صورت یکسان استفاده خواهند کرد.
در مجموع 20 بیمار وارد مطالعه می شوند که به صورت 40 نیمه صورت راست/چپ در نظر گرفته می شوند و به 2 گروه 20 نفره تقسیم می شوند که به صورت تصادفی کرم سیاه دانه یا کرم ترتینونیئن به مدت 8 هفته دریافت می کنند. در طول درمان و دوره ی یک ماهه ی فالوآپ، بیماران از شوینده و ضدآفتاب صورت یکسان استفاده خواهند کرد.
در مجموع 4020 بیمار وارد مطالعه می شوند که به صورت 8040 نیمه صورت راست/چپ در نظر گرفته می شوند و به 2 گروه 4020 نفره تقسیم می شوند که به صورت تصادفی کرم سیاه دانه یا کرم ترتینونیئن به مدت 128 هفته دریافت می کنند. در طول درمان و دوره ی سهیک ماهه ی فالوآپ، بیماران از شوینده و ضدآفتاب صورت یکسان استفاده خواهند کرد.
The main outcome variables are acne lesion counts, reduction of GAGS score ,and the adverse reactions of the intervention medications.
Acne lesion counts; reduction of GAGS score; the adverse reactions of the intervention medications.
The main outcome variables are acneAcne lesion counts,; reduction of GAGS score ,and; the adverse reactions of the intervention medications.
General information
Triple blinded
Double blinded
tripldoubl
1
1
1
1
1
1
1
1
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20
20
No
Yes
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2
2
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2020-11-01, 1399/08/11
2020-11-01 00:00:00
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2021-10-01, 1400/07/09
2021-10-01 00:00:00
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2022-01-05, 1400/10/15
2022-01-05 00:00:00
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Firstly, due to COVID pandemy, sample size and treatment duration were decreased, additionally, completing the study took longer time than expected. Secondly, in order to assess the acne lesions more detailedly, the study took place in The Center of Research and Training in Skin Diseases and Leprosy, in which its equipments (visiopore device, tewameter, corneometer, pHmeter, and mexameter probes) were employed.
Firstly, due to COVID pandemy, sample size and treatment duration were decreased, additionally, completing the study took longer time than expected. Secondly, in order to assess the acne lesions more detailedly, the study took place in The Center of Research and Training in Skin Diseases and Leprosy, in which its equipments (visiopore device, tewameter, corneometer, pHmeter, and mexameter probes) were employed.
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به دلیل پاندمی کووید، حجم نمونه و طول درمان کاهش داده شدند، به علاوه، زمان پایان مطالعه از زمان پیش بینی شده بیشتر به درازا کشید. برای معاینات دقیق تر ضایعات آکنه، محل انجام مطالعه به مرکز آموزش و پزوهش بیماری های پوست و جذام تغییر پیداکرد و از تجهیزات این مرکز (دستگاه ویزیوپور، پروب توامتر، کورنئومتر، پی اچ متر و مگزامتر) استفاده شد.
به دلیل پاندمی کووید، حجم نمونه و طول درمان کاهش داده شدند، به علاوه، زمان پایان مطالعه از زمان پیش بینی شده بیشتر به درازا کشید. برای معاینات دقیق تر ضایعات آکنه، محل انجام مطالعه به مرکز آموزش و پزوهش بیماری های پوست و جذام تغییر پیداکرد و از تجهیزات این مرکز (دستگاه ویزیوپور، پروب توامتر، کورنئومتر، پی اچ متر و مگزامتر) استفاده شد.
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left triple-blind comparative clinial trial
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left double-blind comparative clinical trial
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left tripledouble-blind comparative clinialclinical trial
اثربخشی و ايمنی کرم سیاه دانه 20% در مقايسه با کرم ترتینوئین 0.05% در آکنه ولگاریس: كارآزمايی بالينی تصادفی، سه سويه كور
اثربخشی و ايمنی کرم سیاه دانه 20% در مقايسه با کرم ترتینوئین 0.05% در آکنه ولگاریس: كارآزمايی بالينی تصادفی، دو سويه كور
اثربخشی و ايمنی کرم سیاه دانه 20% در مقايسه با کرم ترتینوئین 0.05% در آکنه ولگاریس: كارآزمايی بالينی تصادفی، سهدو سويه كور
Age between 18-50 years regardless of gender
Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist
Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation
Age between 18-50 years
Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist
Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation
Age between 18-50 years regardless of gender Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation
The 40 patients are considered as 80 half faces and are allocated into two comparison groups. Simple randomization procedure, dice rolling, with a 1 : 1 allocation ratio will be performed as fallowing: for the right half face, the odd numbers are to receive black seed cream, and the even numbers tretinoin 0.05%. The left half of the face is to receive the reverse medication so as to make comparison of 2 medications in the same subject.
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream. The 20 patients were considered as 40 half faces and were randomly allocated into two comparison groups. Simple randomization procedure with an 1 : 1 allocation ratio was performed as following: subjects with odd admission numbers were supposed as ‘right half-face: odd-numbered tube’ (group I) and the ones with even admission numbers were assumed as ‘left half-face: odd-numbered tube’ (group II). In each case, the reverse half-face was given an even-numbered tubes.
TheTreatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream. The 20 patients arewere considered as 8040 half faces and arewere randomly allocated into two comparison groups. Simple randomization procedure, dice rolling, with aan 1 : 1 allocation ratio will bewas performed as fallowingfollowing: for the subjects with odd admission numbers were supposed as ‘right half-face, the: odd numbers are to receive black seed cream,-numbered tube’ (group I) and the ones with even admission numbers tretinoin 0.05%. The were assumed as ‘left half of the -face is to receive: odd-numbered tube’ (group II). In each case, the reverse medication so as to make comparison of 2 medications in the same subjecthalf-face was given an even-numbered tubes.
40 بیمار به صورت 80 نیمه ی صورت در نظر گرفته می شوند و به 2 گروه براساس تصادفی سازی ساده، انداختن تاس، تقسیم می شوند. برای نیمه ی راست صورت، اعداد فرد کرم سیاه دانه و اعداد زوج کرم ترتینوئین 0.05% دریافت می کنند. نیمه ی چپ صورت داروی معکوس را دریافت میکند به این منظور که هر دو کرم در یک شخص مورد مقایسه قرار گیرند.
تیوب کرم ها توسط یک نفر سوم غیر دخیل در مطالعه به صورت تصادفی از 1 تا 40 شماره گذاری شدند به طوری که تیوب با شماره فرد حاوی کرم سیاه دانه و تیوب با شماره زوج حاوی کرم ترتینوئین بودند. 20 بیمار به صورت 40 نیمه ی صورت در نظر گرفته شده و به صورت تصادفی به 2 گروه تقسیم شدند. تصادفی سازی ساده با نسبت 1 : 1 به این شکل صورت پذیزفت: داوطلبین با شماره مراجعه فرد "نیمه راست صورت : تیوب با شماره فرد" (گروه 1) و افراد با شماره مراجعه زوج "نیمه چپ صورت : تیوب با شماره فرد" (گروه 2) دریافت کردند. در هر گروه نیمه ی دیگر صورت داروی معکوس را دریافت کرد.
تیوب کرم ها توسط یک نفر سوم غیر دخیل در مطالعه به صورت تصادفی از 1 تا 40 شماره گذاری شدند به طوری که تیوب با شماره فرد حاوی کرم سیاه دانه و تیوب با شماره زوج حاوی کرم ترتینوئین بودند. 20 بیمار به صورت 8040 نیمه ی صورت در نظر گرفته می شوندشده و به صورت تصادفی به 2 گروه براساستقسیم شدند. تصادفی سازی ساده، انداختن تاس، تقسیم می شوند با نسبت 1 : 1 به این شکل صورت پذیزفت: داوطلبین با شماره مراجعه فرد "نیمه راست صورت : تیوب با شماره فرد" (گروه 1) و افراد با شماره مراجعه زوج "نیمه چپ صورت : تیوب با شماره فرد" (گروه 2) دریافت کردند. برایدر هر گروه نیمه ی راست صورت، اعداد فرد کرم سیاه دانه و اعداد زوج کرم ترتینوئین 0.05% دریافت می کنند. نیمه ی چپدیگر صورت داروی معکوس را دریافت میکند به این منظور که هر دو کرم در یک شخص مورد مقایسه قرار گیرندکرد.
The allocation sequence will be only known to a person who is not involved in study process; the patients, healthcare providers,and statistical specialist are all blinded.The aforementioned person will label identical sealed aluminum tubes of black seed 20% and tretinoin 0.05% in cream forms as either “left” or “right” for each participant half face according to the allocation sequence.
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream.
The allocation sequence will be only known toTreatment tubes were randomly labeled by a person who isthird party not involved in the study process;from 1 to 40 so that the patients, healthcare providers,and statistical specialist are all blinded.The aforementioned person will label identical sealed aluminum tubes of black seedwith odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% in cream forms as either “left” or “right” for each participant half face according to the allocation sequence.
فقط یک شخص که خارج از عملیات مطالعه می باشد از نحوه ی تقسیم بندی اطلاع دارد، بیماران ، کادر درمان و آماریست همگی کور می باشند. شخص مطلع تیوب های آلومینیومی یک شکل کرم های سیاه دانه 20% و ترتینوئین 0.05% را به شکل "راست" یا "چپ" برای نیمه ی صورت بیمار برچسب گذاری می کند.
تیوب کرم ها توسط یک نفر سوم غیر دخیل در مطالعه به صورت تصادفی از 1 تا 40 شماره گذاری شدند به طوری که تیوب با شماره فرد حاوی کرم سیاه دانه و تیوب با شماره زوج حاوی کرم ترتینوئین بودند.
فقطتیوب کرم ها توسط یک شخصنفر سوم غیر دخیل در مطالعه به صورت تصادفی از 1 تا 40 شماره گذاری شدند به طوری که خارج از عملیات مطالعه می باشد از نحوه ی تقسیم بندی اطلاع دارد، بیماران ، کادر درمان و آماریست همگی کور می باشند. شخص مطلع تیوب های آلومینیومی یک شکلبا شماره فرد حاوی کرم های سیاه دانه 20% و تیوب با شماره زوج حاوی کرم ترتینوئین 0.05% را به شکل "راست" یا "چپ" برای نیمه ی صورت بیمار برچسب گذاری می کندبودند.
One half of the face will receive Tretinoin cream while in the other half, Black seed cream will be applied.
One half of the face will receive tretinoin cream while in the other half, black seed cream will be applied.
One half of the face will receive Tretinointretinoin cream while in the other half, Blackblack seed cream will be applied.
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One half of the face received tretinoin cream, and the other half, back seed cream
One half of the face received tretinoin cream, and the other half, back seed cream
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براي يك نيمه ي صورت كرم ترتينوئين و براي نيمه ديگر كرم سياه دانه استعمال شد
براي يك نيمه ي صورت كرم ترتينوئين و براي نيمه ديگر كرم سياه دانه استعمال شد
Primary outcomes
#1
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly clinical examination in a three-month follow-up period by 2 dermatologists
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition, and one month after discontinuation of monthly clinical examination in a three-month follow-up period by 2 dermatologiststreatments (the 12th week after baseline)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه، ارزیابی بالینی توسط دو متخصص درماتولوژی صورت می گیرد
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه، ارزیابی بالینی توسط دو متخصص درماتولوژی صورت می گیردیک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
#2
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly clinical examination in a three-month follow-up period by 2 dermatologists
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition, and one month after discontinuation of monthly clinical examination in a three-month follow-up period by 2 dermatologiststreatments (the 12th week after baseline)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه، ارزیابی بالینی توسط دو متخصص درماتولوژی صورت می گیرد
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه، ارزیابی بالینی توسط دو متخصص درماتولوژی صورت می گیردیک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
#3
Baseline (before intervention) and 4, 8, 12 weeks after intervention with the addition of monthly visits in a three-month follow-up period
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4, 8, 12 weeks after intervention with the addition, and one month after discontinuation of monthly visits in a three-month follow-up periodtreatments (the 12th week after baseline)
در ابتدای مطالعه (قبل از شروع مداخله) و هفته های 4 ،8 ،12 پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه بعد از اتمام مداخله
4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و هفته های 4 ،8 ،12هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماههیک ماه بعد از اتمام مداخلهقطع درمان (هفته 12ام بعد از شروع مطالعه)
#4
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly visits in a three-month follow-up period
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition, and one month after discontinuation of monthly visits in a three-month follow-up periodtreatments (the 12th week after baseline)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماهه بعد از اتمام مداخله
4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین به صورت ماهانه در دوره ی فالوآپ سه ماههیک ماه بعد از اتمام مداخلهقطع درمان (هفته 12ام بعد از شروع مطالعه)
#5
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition of monthly assessments in a three-month follow-up period by 2 dermatologists
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8, 12 weeks after intervention with the addition, and one month after discontinuation of monthly assessments in a three-month follow-up period by 2 dermatologiststreatments (the 12th week after baseline)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین ارزیابی ماهانه در دوره ی فالوآپ سه ماهه توسط دو متخصص درماتولوژی صورت می گیرد
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 ، 12 هفته پس از شروع مصرف داروهای مطالعه و همچنین ارزیابی ماهانه در دوره ی فالوآپ سه ماهه توسط دو متخصص درماتولوژی صورت می گیردیک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
#6
empty
Visiopore parameters (quantity, size, and value)
Visiopore parameters (quantity, size, and value)
empty
پارامتر های دستگاه ویزیوپور (تعداد، سایز و شدت)
پارامتر های دستگاه ویزیوپور (تعداد، سایز و شدت)
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
Visiopore device
Visiopore device
empty
دستگاه ویزیوپور
دستگاه ویزیوپور
#7
empty
skin hydration
skin hydration
empty
میزان رطوبت پوست
میزان رطوبت پوست
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
Corneometer probe
Corneometer probe
empty
پروب کورنئومتر
پروب کورنئومتر
#8
empty
skin erythema
skin erythema
empty
اریتما پوست
اریتما پوست
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
mexameter probe
mexameter probe
empty
پروب مگزامتر
پروب مگزامتر
#9
empty
skin melanin
skin melanin
empty
ملانین پوست
ملانین پوست
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
mexameter probe
mexameter probe
empty
پروب مگزامتر
پروب مگزامتر
#10
empty
Transepidermal water loss
Transepidermal water loss
empty
میزان تبخیر اب سطحی پوست
میزان تبخیر اب سطحی پوست
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
Tewameter probe
Tewameter probe
empty
پروب توامتر
پروب توامتر
#11
empty
Skin pH
Skin pH
empty
پی اچ پوست
پی اچ پوست
empty
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
empty
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
در ابتدای مطالعه (قبل از شروع مداخله) و 4 ، 8 هفته پس از شروع مصرف داروهای مطالعه و یک ماه بعد از قطع درمان (هفته 12ام بعد از شروع مطالعه)
empty
pHmeter probe
pHmeter probe
empty
پروب پی اچ متر
پروب پی اچ متر
Intervention groups
#1
40 patients are considered as 80 half faces ,and 2 comparison groups are designed as 40 right and 40 left half faces in order to omit the interindividual differences and compare each participant responses to the medications with her/himself. Patients will be individually instructed to apply a thin layer of the given topical medications which are labelled as "left" and "right" on the determined side of the clean facial skin for 12 weeks as twice daily administration. In the three-month follow-up period, the patients will use identical facial cleansers and sunscreens.
20 patients are considered as 40 half faces ,and 2 comparison groups are designed as 20 right and 20 left half faces in order to omit the interindividual differences and compare each participant responses to the medications with her/himself. Patients will be individually instructed to apply a thin layer of the given topical medications which are labelled as "left" and "right" on the determined side of the clean facial skin for 8 weeks as twice daily administration. Through the treatment period and the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
4020 patients are considered as 8040 half faces ,and 2 comparison groups are designed as 4020 right and 4020 left half faces in order to omit the interindividual differences and compare each participant responses to the medications with her/himself. Patients will be individually instructed to apply a thin layer of the given topical medications which are labelled as "left" and "right" on the determined side of the clean facial skin for 128 weeks as twice daily administration. InThrough the threetreatment period and the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
40 بیمار به شکل 80 نیمه صورت در نظر گرفته می شوند و دو گروه مقایسه به صورت یک گروه 40 نفره نیمه راست و یک گروه 40 نفره نیمه چپ خواهند بود، به این منظور که اختلافات بین فردی از میان برداشته شده و پاسخ های هر بیمار به داروها با خود بیمار مورد مقایسه قرار گیرد. به بیماران به صورت فردی آموزش داده خواهد شد که کرم های موضعی داده شده را طبق برچسب مشخص شده بر روی نیمه ی چپ/راست صورت خود روزانه دو بار، به مدت 12 هفته استعمال نمایند. در دوره ی سه ماهه ی فالوآپ، بیماران پاک کننده و ضدآفتاب صورت یکسان دریافت خواهند کرد.
20 بیمار به شکل 40 نیمه صورت در نظر گرفته می شوند و دو گروه مقایسه به صورت یک گروه 20 نفره نیمه راست و یک گروه 20 نفره نیمه چپ خواهند بود، به این منظور که اختلافات بین فردی از میان برداشته شده و پاسخ های هر بیمار به داروها با خود بیمار مورد مقایسه قرار گیرد. به بیماران به صورت فردی آموزش داده خواهد شد که کرم های موضعی داده شده را طبق برچسب مشخص شده بر روی نیمه ی چپ/راست صورت خود روزانه دو بار، به مدت 8 هفته استعمال نمایند. در طول درمان و دوره ی یک ماهه ی فالوآپ، بیماران پاک کننده و ضدآفتاب صورت یکسان دریافت خواهند کرد.
4020 بیمار به شکل 8040 نیمه صورت در نظر گرفته می شوند و دو گروه مقایسه به صورت یک گروه 4020 نفره نیمه راست و یک گروه 4020 نفره نیمه چپ خواهند بود، به این منظور که اختلافات بین فردی از میان برداشته شده و پاسخ های هر بیمار به داروها با خود بیمار مورد مقایسه قرار گیرد. به بیماران به صورت فردی آموزش داده خواهد شد که کرم های موضعی داده شده را طبق برچسب مشخص شده بر روی نیمه ی چپ/راست صورت خود روزانه دو بار، به مدت 128 هفته استعمال نمایند. در طول درمان و دوره ی سهیک ماهه ی فالوآپ، بیماران پاک کننده و ضدآفتاب صورت یکسان دریافت خواهند کرد.
Recruitment centers
#1
Name of recruitment center - English: Dr Ali Shariati hospital
Name of recruitment center - Persian: بیمارستان دکتر علی شریعتی
Full name of responsible person - English: Dr. Zahra Azizian
Full name of responsible person - Persian: دکتر زهرا عزیزیان
Street address - English: Dr Shariati hopital, Mahdasht, Karaj, Alborz, Iran
Street address - Persian: استان البرز - کرج -جاده محمد شهر به ماهدشت- بیمارستان و زایشگاه دکتر علی شریعتی
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 19419
Phone: +98 21 2264 0056
Fax:
Email: azizian.z@yahoo.com
Web page address:
Name of recruitment center - English: Center for Research & Training in Skin Diseases & Leprosy
Name of recruitment center - Persian: مرکز اموزش و پژوهش بیماری های پوست و جذام
Full name of responsible person - English: Dr. Alireza Firooz
Full name of responsible person - Persian: دکتر علیرضا فیروز
Street address - English: The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave.
Street address - Persian: مرکز اموزش و پژوهش بیماری های پوست و جذام، خیابان طالقانی، نبش خیابان شهید نادری (سهیل سابق)، شماره 415
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416613675
Phone: +98 21 8896 0880
Fax:
Email: dermalab@tums.ac.ir
Web page address:
Name of recruitment center - English: Dr Ali Shariati hospitalCenter for Research & Training in Skin Diseases & Leprosy Name of recruitment center - Persian: بیمارستان دکتر علی شریعتیمرکز اموزش و پژوهش بیماری های پوست و جذام Full name of responsible person - English: Dr. Zahra AzizianAlireza Firooz Full name of responsible person - Persian: دکتر زهرا عزیزیانعلیرضا فیروز Street address - English: Dr Shariati hopitalThe Center for Research and Training in Skin Diseases and Leprosy, MahdashtNo. 415, KarajNaderi St., Alborz, IranTaleghani Ave. Street address - Persian: استان البرز - کرج -جاده محمد شهر به ماهدشت- بیمارستانمرکز اموزش و زایشگاه دکتر علی شریعتیپژوهش بیماری های پوست و جذام، خیابان طالقانی، نبش خیابان شهید نادری (سهیل سابق)، شماره 415 City - English: KarajTehran City - Persian: کرجتهران Province: AlborzTehran Country: Iran (Islamic Republic of) Postal code: 194191416613675 Phone: +98 21 2264 00568896 0880 Fax: Email: azizian.zdermalab@yahoo.comtums.ac.ir Web page address:
#2
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: بیمارستان رازی
Full name of responsible person - English: Dr. Maryam Daneshpazhooh
Full name of responsible person - Persian: دکتر مريم دانش پژوه
Street address - English: Razi Hospital, Vahdat Eslami Square
Street address - Persian: بیمارستان رازی، میدان وحدت اسلامی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1199663911
Phone: +98 21 5563 0223
Fax:
Email: razihospital@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Razi Hospital Name of recruitment center - Persian: بیمارستان رازی Full name of responsible person - English: Dr. Maryam Daneshpazhooh Full name of responsible person - Persian: دکتر مريم دانش پژوه Street address - English: Razi Hospital, Vahdat Eslami Square Street address - Persian: بیمارستان رازی، میدان وحدت اسلامی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1199663911 Phone: +98 21 5563 0223 Fax: Email: razihospital@sina.tums.ac.ir Web page address:
Protocol summary
Study aim
This clinical trial aims to compare the effects of black seed cream with tretinoin cream in acne vulgaris
Design
This study is a double-blind randomized clinical trial.
Settings and conduct
This clinical trial will be conducted in The Center for Research and Training in Skin Diseases and Leprosy, and Razi hospital of Tehran University of medical sciences. Participants and healthcare providers will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: individuals aged between 18-50 years old (regardless of gender) diagnosed with mild to moderate facial acne vulgaris (GAGS score ranging from 1 to 30); discontinued any topical or systemic treatments for acne at least 3 months prior to the intervention. Exclusion criteria: women with hirsutism or hormonal problems, pregnancy, breastfeeding, sensitivity to tretinoin or balck seed, and candidates for isotretinoin treatment.
Intervention groups
The number of 20 patients participating in this study are considered as 40 half faces, and are allocated into 2 equal groups receiving either tretinoin 0.05% or black seed creams for 8 weeks. Through the treatment period and in the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
Main outcome variables
Acne lesion counts; reduction of GAGS score; the adverse reactions of the intervention medications.
General information
Reason for update
Firstly, due to COVID pandemy, sample size and treatment duration were decreased, additionally, completing the study took longer time than expected. Secondly, in order to assess the acne lesions more detailedly, the study took place in The Center of Research and Training in Skin Diseases and Leprosy, in which its equipments (visiopore device, tewameter, corneometer, pHmeter, and mexameter probes) were employed.
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045173N1
Registration date:2020-04-03, 1399/01/15
Registration timing:prospective
Last update:2022-02-09, 1400/11/20
Update count:1
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Sarvenaz Zandkarimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0051
Email address
sarvenazkarimi96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2020-11-01, 1399/08/11
Actual recruitment end date
2021-10-01, 1400/07/09
Trial completion date
2022-01-05, 1400/10/15
Scientific title
Efficacy and safety of Nigella sativa cream (20%) vs. tretinoin cream (0.05%) for acne vulgaris: a randomized right/left double-blind comparative clinical trial
Public title
Black seed vs. Tretinoin in acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-50 years
Clinical diagnosis of mild to moderate facial acne (GAGS score ranging from 1 to 30) made by a dermatologist
Discontinuation of any topical or systemic treatment for acne from at least 3 months prior to participation
Exclusion criteria:
Pregnancy or lactation,
Women with hirsutism, menstrual disorders and hormonal problems,
Severe grade of acne,
Candidate for isotretinoin treatment,
Known allergy to black seed or tretinoin,
Subjects who are non-cooperative or unsatisfied with the treatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
One half of the face will receive tretinoin cream while in the other half, black seed cream will be applied.
Actual sample size reached:
20
More than 1 sample in each individual
Actual sample size in each individual:
2
One half of the face received tretinoin cream, and the other half, back seed cream
Randomization (investigator's opinion)
Randomized
Randomization description
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream. The 20 patients were considered as 40 half faces and were randomly allocated into two comparison groups. Simple randomization procedure with an 1 : 1 allocation ratio was performed as following: subjects with odd admission numbers were supposed as ‘right half-face: odd-numbered tube’ (group I) and the ones with even admission numbers were assumed as ‘left half-face: odd-numbered tube’ (group II). In each case, the reverse half-face was given an even-numbered tubes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment tubes were randomly labeled by a third party not involved in the study from 1 to 40 so that the tubes with odd numbers contained NS 20% cream and the ones with even numbers contained tretinoin 0.05% cream.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical Sciences
Street address
Faculty of pharmacy, Islamic Azad University of Medical Sciences, Yasaman Alley, Yakhchal Street, District 1, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.IAU.TMU.REC.1398.171
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Acne lesion counts
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Independent assessment of lesion counts: comedones, papules/pustules
2
Description
Reduction of Global Acne Grading System (GAGS) score
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Rating of acne according to Global Acne Grading System (GAGS) by two dermatologists
3
Description
Patients satisfaction
Timepoint
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Patient subjective satisfaction score ranging from 1 to 100
4
Description
Adverse reactions of the study medications
Timepoint
4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Patients reports and clinical assessments by two dermatologists
5
Description
Photographic assessment
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Digital camera
6
Description
Visiopore parameters (quantity, size, and value)
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Visiopore device
7
Description
skin hydration
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Corneometer probe
8
Description
skin erythema
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
mexameter probe
9
Description
skin melanin
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
mexameter probe
10
Description
Transepidermal water loss
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
Tewameter probe
11
Description
Skin pH
Timepoint
Baseline (before intervention) and 4 , 8 weeks after intervention, and one month after discontinuation of treatments (the 12th week after baseline)
Method of measurement
pHmeter probe
Secondary outcomes
empty
Intervention groups
1
Description
20 patients are considered as 40 half faces ,and 2 comparison groups are designed as 20 right and 20 left half faces in order to omit the interindividual differences and compare each participant responses to the medications with her/himself. Patients will be individually instructed to apply a thin layer of the given topical medications which are labelled as "left" and "right" on the determined side of the clean facial skin for 8 weeks as twice daily administration. Through the treatment period and the one-month follow-up period, the patients will use identical facial cleansers and sunscreens.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research & Training in Skin Diseases & Leprosy
Full name of responsible person
Dr. Alireza Firooz
Street address
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
dermalab@tums.ac.ir
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Maryam Daneshpazhooh
Street address
Razi Hospital, Vahdat Eslami Square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2260 9043
Email
sarvenazkarimi96@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2264 0056
Email
mehdirj@aol.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Zahra Azizian
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 2264 0056
Fax
Email
azizian.z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sarvenaz Zandkarimi
Position
Pharm. D.
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19419
Phone
+98 21 2264 0056
Email
sarvenazkarimi96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only the data related to the measured outcomes will be published
When the data will become available and for how long
Availability starts after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
Applicants aught to send a request email containing their aims and how the data will be used to the given gmail address
From where data/document is obtainable
contact: Sarvenazkarimi96@gmail.com
What processes are involved for a request to access data/document
After assessment of the applicant's request, if agreed, the data files will be sent in the shortest possible time .