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IRCT20191021045173N1 IRCT 2020-04-03 Islamic Azad University Black seed vs. Tretinoin in acne vulgaris 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 2020-04-08 anticipated 40 Complete https://irct.ir/trial/43162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Acne vulgaris. 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.. Yes - There is a plan to make this available What will be shared: Only the data related to the measured outcomes will be published When: Availability starts after publication To whom: Available for people working in academic institutions Conditions: Applicants aught to send a request email containing their aims and how the data will be used to the given gmail address Where to obtain: contact: Sarvenazkarimi96@gmail.com How to obtain: After assessment of the applicant's request, if agreed, the data files will be sent in the shortest possible time . Comments:
public Dr. Mehdi Rajabi
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 19419 +98 21 2264 0056 mehdirj@aol.co.uk Islamic Azad University scientific Dr. Zahra Azizian
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 2264 0056 azizian.z@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 50 years Both 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 L70.0 Acne vulgaris Treatment - Drugs 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Islamic Azad University Approved 2019-12-04 Ethics committee of Tehran Islamic Azad University of Medical Sciences Faculty of pharmacy, Islamic Azad University of Medical Sciences, Yasaman Alley, Yakhchal Street, District 1, Tehran. Tehran Tehran Iran (Islamic Republic of)