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Active Post Marketing Surveillance to Evaluate the Efficacy and Safety of bFGF in Combination with NBUVB for the Treatment of Vitiligo; A Triple-blind, Randomized, Placebo-controlled Clinical Trial

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History
# Registration date Revision Id
2 2021-10-12, 1400/07/20 201180
1 2021-07-08, 1400/04/17 189456
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  • Protocol summary

    Evaluating the efficacy and safety of bFGF in combination with NBUVB for the treatment vitiligo on the face
    Evaluating the efficacy and safety of bFGF in combination with NBUVB for the treatment vitiligo
    بررسی اثربخشی و ایمنی استفاده از سرم bFGF همراه با NBUVB در بهبود لکه های ویتیلیگو در صورت
    بررسی اثربخشی و ایمنی استفاده از سرم bFGF همراه با NBUVB در بهبود لکه های ویتیلیگو
    Inclusion criteria: Male or females aged 18 to 65, signed the informed consent form, Diagnosis of non-segmental vitiligo in the facial area, Stable vitiligo for at least 6 months, Candidate for phototherapy, Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks, Have not been receiving phototherapy during the past 6 months, Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator, Patients with general good health (except vitiligo) as judged by the Investigator Exclusion criteria: Women of childbearing potential, or breastfeeding, Diagnosis of extensive or unstable vitiligo, Patients with skin cancer or precancerous skin lesions, Patients with poliosis in > 50% of their vitiligo patches, Patients with complete facial depigmentation, Diagnosis of segmental or mixed vitiligo, Subjects whose vitiligo has not responded to phototherapy or patients who have received phototherapy in the past 6 months, Patients with contraindication to NBUVB, Patients with known allergy to the product's excipients
    Inclusion criteria: Male or females aged 18 to 65, signed the informed consent form, Diagnosis of non-segmental vitiligo not more than 5 years, Stable vitiligo for at least 6 months, Candidate for phototherapy, Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks, Have not been receiving phototherapy during the past 6 months, Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator, Patients with general good health (except vitiligo) as judged by the Investigator Exclusion criteria: Women of childbearing potential, or breastfeeding, Diagnosis of extensive or unstable vitiligo, Patients with skin cancer or precancerous skin lesions, Patients with poliosis in > 50% of their vitiligo patches, Patients with complete facial depigmentation, Diagnosis of segmental or mixed vitiligo, Subjects whose vitiligo has not responded to phototherapy or patients who have received phototherapy in the past 6 months, Patients with contraindication to NBUVB, Patients with known allergy to the product's excipients
    معیارهای ورود: بیماران زن یا مرد با سن 18-65 رضایت به شرکت در مطالعه و امضاء فرم رضایت نامه آگاهانه تشخیص ویتیلیگو non -segmental در ناحیه ی صورت که بیشتر از 1 سال از ابتلا نگذشته باشد ضایعات پایدار حداقل به مدت 6 ماه کاندید فوتوتراپی باشد بیماران در طی 6 هفته ی گذشته داروی سیستمیک یا موضعی برای درمان ویتیلیگو دریافت نکرده باشند. در صورت فتوتراپی قبلی، بیش از 6 ماه از درمان گذشته باشد. بیمار فاقد هر گونه بیماری یا شرایط جسمی شناخته شده ای باشد که از نظر محقق در ارزیابی های مطالعه تداخل ایجاد می کند یا با مشارکت در مطالعه داوطلب را در معرض خطر بی مورد قرار می دهد. افرادی که طبق نظر پزشک محقق اصلی از سلامت عمومی مناسبی (به جز ابتلا به ویتیلیگو) برخوردارند. معیارهای عدم ورود: زنان باردار یا شیرده عدم رضایت برای ورود به طرح تحقیقاتی ویتیلیگو گسترده یا در حال پیشرفت افرادی که دچار سرطان پوست یا ضایعات پیش سرطانی پوست باشند افراد دارای شواهد پولیوز در> 50٪ ضایعات ویتیلیگو افراد با دپیگمنتاسیون کامل صورت. افرادی که دارای ویتیلیگو سگمنتالmixed, هستند افرادی که در فتوتراپی شکست خورده اند یا کمتر از 6 ماه از انجام فتوتراپی قبلی گذشته باشد. هر گونه منع مصرف برای فتوتراپی افراد دارای سابقه حساسیت به هر یک از مواد تشکیل دهنده سرم
    معیارهای ورود: بیماران زن یا مرد با سن 18-65 رضایت به شرکت در مطالعه و امضاء فرم رضایت نامه آگاهانه تشخیص ویتیلیگو non -segmental که بیشتر از 5 سال از ابتلا نگذشته باشد ضایعات پایدار حداقل به مدت 6 ماه کاندید فوتوتراپی باشد بیماران در طی 6 هفته ی گذشته داروی سیستمیک یا موضعی برای درمان ویتیلیگو دریافت نکرده باشند. در صورت فتوتراپی قبلی، بیش از 6 ماه از درمان گذشته باشد. بیمار فاقد هر گونه بیماری یا شرایط جسمی شناخته شده ای باشد که از نظر محقق در ارزیابی های مطالعه تداخل ایجاد می کند یا با مشارکت در مطالعه داوطلب را در معرض خطر بی مورد قرار می دهد. افرادی که طبق نظر پزشک محقق اصلی از سلامت عمومی مناسبی (به جز ابتلا به ویتیلیگو) برخوردارند. معیارهای عدم ورود: زنان باردار یا شیرده عدم رضایت برای ورود به طرح تحقیقاتی ویتیلیگو گسترده یا در حال پیشرفت افرادی که دچار سرطان پوست یا ضایعات پیش سرطانی پوست باشند افراد دارای شواهد پولیوز در> 50٪ ضایعات ویتیلیگو افراد با دپیگمنتاسیون کامل صورت. افرادی که دارای ویتیلیگو سگمنتالmixed, هستند افرادی که در فتوتراپی شکست خورده اند یا کمتر از 6 ماه از انجام فتوتراپی قبلی گذشته باشد. هر گونه منع مصرف برای فتوتراپی افراد دارای سابقه حساسیت به هر یک از مواد تشکیل دهنده سرم

  • General information

    empty
    Change in the study title (after ethics committee approval)
    empty
    تغییر عنوان مطالعه (پس از اطلاع و تایید کمیته ی اخلاق)
    Phase IV Clinical Trial to Evaluate the Efficacy and Safety of basic Fibroblast Growth Factor Compared to Placebo in Combination with NBUVB for the Treatment of Vitiligo Patches on the Face
    Phase IV Clinical Trial to Evaluate the Efficacy and Safety of basic Fibroblast Growth Factor Compared to Placebo in Combination with NBUVB for the Treatment of Vitiligo
    مطالعه ی بالینی فاز چهار برای بررسی اثربخشی و ایمنی سرم آرایشی حاوی فاکتور بازی رشد فیبروبلاست در مقایسه با دارونما همراه با نور درمانی در بهبود ضایعات ناشی از ویتیلیگو در صورت
    مطالعه ی بالینی فاز چهار برای بررسی اثربخشی و ایمنی سرم آرایشی حاوی فاکتور بازی رشد فیبروبلاست در مقایسه با دارونما همراه با نور درمانی در بهبود ضایعات ناشی از ویتیلیگو
    Active Post Marketing Surveillance to Evaluate the Efficacy and Safety of bFGF in Combination with NBUVB for the Treatment of Vitiligo Patches on the Face; A Triple-blind, Randomized, Placebo-controlled Clinical Trial
    Active Post Marketing Surveillance to Evaluate the Efficacy and Safety of bFGF in Combination with NBUVB for the Treatment of Vitiligo; A Triple-blind, Randomized, Placebo-controlled Clinical Trial
    مطالعه Active Post Marketing Surveillance فاز 4، سه سو کور تصادفی برای بررسی اثربخشی و ایمنی مرتبط با استفاده از سرم پپتید bFGF (فاکتور رشد بازی فیبروبلاست -ساخته شده توسط هیوا زیست پویا البرز) در مقایسه با سرم حامل فرآورده (پلاسبو) همراه با فتوتراپی در بهبود لکه های ناشی از ویتیلیگو در صورت
    مطالعه Active Post Marketing Surveillance فاز 4، سه سو کور تصادفی برای بررسی اثربخشی و ایمنی مرتبط با استفاده از سرم پپتید bFGF (فاکتور رشد بازی فیبروبلاست) در مقایسه با سرم حامل فرآورده (پلاسبو) همراه با فتوتراپی در بهبود لکه های ناشی از ویتیلیگو
    - Male or female patients aged 18 to 65 years
    - Willingly signed the written informed consent form
    - Diagnosis of non-segmental vitiligo in the facial area no longer than 1 year with symmetrical lesions except for the eyelids
    - Stable vitiligo for at least 6 months (no new patches, or less than 10% increase in the diameter of the existing patches for at least 6 months
    - Candidate for phototherapy (more than 25% body surface involvement)
    - Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks
    - Have not been receiving phototherapy during the past 6 months
    - Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator
    - Patients with general good health (except vitiligo) as judged by the Investigator
    - Male or female patients aged 18 to 65 years
    - Willingly signed the written informed consent form
    - Diagnosis of non-segmental vitiligo no longer than 5 years with symmetrical lesions except for the eyelids
    - Stable vitiligo for at least 6 months (no new patches, or less than 10% increase in the diameter of the existing patches for at least 6 months
    - Candidate for phototherapy (more than 25% body surface involvement)
    - Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks
    - Have not been receiving phototherapy during the past 6 months
    - Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator
    - Patients with general good health (except vitiligo) as judged by the Investigator
    - بیماران زن یا مرد با سن 18-65 سال
    - رضایت به شرکت در مطالعه و امضاء فرم رضایت نامه آگاهانه
    - تشخیص ویتیلیگو non -segmental در ناحیه ی صورت که بیشتر از 1 سال از ابتلا نگذشته باشد و ضایعات قرینه به استثنای پلک های بالا و پایین
    - ضایعات پایدار حداقل به مدت 6 ماه (هیچ گونه ضایعه جدیدی طی 6 ماه گذشته دیده نشده باشد یا 10% یا کمتر افزایش در قطر ضایعات قبلی)
    - کاندید فوتوتراپی باشد (بیشتر از 25% درگیری در سطح بدن)
    - بیماران در طی 6 هفته ی گذشته داروی سیستمیک یا موضعی برای درمان ویتیلیگو دریافت نکرده باشند.
    - در صورت فتوتراپی قبلی، بیش از 6 ماه از درمان گذشته باشد.
    - بیمار فاقد هر گونه بیماری یا شرایط جسمی شناخته شده ای باشد که از نظر محقق در ارزیابی های مطالعه تداخل ایجاد می کند یا با مشارکت در مطالعه داوطلب را در معرض خطر بی مورد قرار می دهد.
    - افرادی که طبق نظر پزشک محقق اصلی از سلامت عمومی مناسبی (به جز ابتلا به ویتیلیگو) برخوردارند.
    - بیماران زن یا مرد با سن 18-65 سال
    - رضایت به شرکت در مطالعه و امضاء فرم رضایت نامه آگاهانه
    - تشخیص ویتیلیگو non -segmental که بیشتر از 5 سال از ابتلا نگذشته باشد و ضایعات قرینه به استثنای پلک های بالا و پایین
    - ضایعات پایدار حداقل به مدت 6 ماه (هیچ گونه ضایعه جدیدی طی 6 ماه گذشته دیده نشده باشد یا 10% یا کمتر افزایش در قطر ضایعات قبلی)
    - کاندید فوتوتراپی باشد (بیشتر از 25% درگیری در سطح بدن)
    - بیماران در طی 6 هفته ی گذشته داروی سیستمیک یا موضعی برای درمان ویتیلیگو دریافت نکرده باشند.
    - در صورت فتوتراپی قبلی، بیش از 6 ماه از درمان گذشته باشد.
    - بیمار فاقد هر گونه بیماری یا شرایط جسمی شناخته شده ای باشد که از نظر محقق در ارزیابی های مطالعه تداخل ایجاد می کند یا با مشارکت در مطالعه داوطلب را در معرض خطر بی مورد قرار می دهد.
    - افرادی که طبق نظر پزشک محقق اصلی از سلامت عمومی مناسبی (به جز ابتلا به ویتیلیگو) برخوردارند.

  • Primary outcomes

    #1
    Comparison of photos taken from facial lesions
    Comparison of photos taken from lesions
    مقایسه ی عکس های گرفته شده از ضایعات صورت
    مقایسه ی عکس های گرفته شده از ضایعات

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Hiva Zist Pouya Alborz
    Name of organization / entity - Persian: هیوا زیست پویا البرز
    Full name of responsible person - English: Dr. Setayesh Sadeghi
    Full name of responsible person - Persian: دکتر ستایش صادقی
    Street address - English: Central part of Garmadreh city, Saadatieh street, Lashkari highway, No. 125, ground floor
    Street address - Persian: بخش مرکزی شهر گرمدره، محله سعادتیه، خیابان سعادتیه، بزرگراه لشکری، پلاک 125، طبق همکف
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 1399114913
    Phone: +98 21 4607 8490
    Fax:
    Email: info@artapharmed.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Imen Vaccine Alborz
    Name of organization / entity - Persian: ایمن واکسن البرز
    Full name of responsible person - English: Dr. Setayesh Sadeghi
    Full name of responsible person - Persian: دکتر ستایش صادقی
    Street address - English: Alborz, Nazarabad, Sepehr Industrial Town, West Bahman St., No. 110
    Street address - Persian: البرز، نظرآباد، شهرک صنعتی سپهر، خیابان بهمن غربی، شماره 110
    City - English: Nazarabad
    City - Persian: نظرآباد
    Province: Alborz
    Country: Iran (Islamic Republic of)
    Postal code: 1399114913
    Phone: +98 26 4533 4189
    Fax:
    Email: info@imenvaccine.com
    Web page address:
    Hiva Zist Pouya Alborz
    Imen Vaccine Alborz
    هیوا زیست پویا البرز
    ایمن واکسن البرز

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Houshang Ehsani
    Full name of responsible person - Persian: امیر هوشنگ احسانی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: specialist
    Area of specialty/work: 42
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vahdat Eslami Square, Tehran, Iran.
    Street address - Persian: خيابان وحدت اسلامي– ميدان وحدت اسلامي– بن بست رازي– بيمارستان تخصصي پوست رازي
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 5563 0553
    Mobile: +98 912 343 6493
    Fax:
    Email: ehsanih@sina.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Houshang Ehsani
    Full name of responsible person - Persian: امیر هوشنگ احسانی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: specialist
    Area of specialty/work: 42
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vahdat Eslami Square, Tehran, Iran.
    Street address - Persian: خيابان وحدت اسلامي– ميدان وحدت اسلامي– بن بست رازي– بيمارستان تخصصي پوست رازي
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۱۹۹۶۶۳۹۱۱
    Phone: +98 21 5563 0553
    Mobile: +98 912 343 6493
    Fax:
    Email: ehsanih@sina.tums.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluating the efficacy and safety of bFGF in combination with NBUVB for the treatment vitiligo
Design
This study will be performed as an active post marketing surveillance phase 4, triple-blind (patient, physician and outcome assessor), placebo-controlled study with a superiority approach to evaluate the efficacy and safety of bFGF peptide serum in the treatment of vitiligo patches on the face.
Settings and conduct
Razi Hospital, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or females aged 18 to 65, signed the informed consent form, Diagnosis of non-segmental vitiligo not more than 5 years, Stable vitiligo for at least 6 months, Candidate for phototherapy, Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks, Have not been receiving phototherapy during the past 6 months, Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator, Patients with general good health (except vitiligo) as judged by the Investigator Exclusion criteria: Women of childbearing potential, or breastfeeding, Diagnosis of extensive or unstable vitiligo, Patients with skin cancer or precancerous skin lesions, Patients with poliosis in > 50% of their vitiligo patches, Patients with complete facial depigmentation, Diagnosis of segmental or mixed vitiligo, Subjects whose vitiligo has not responded to phototherapy or patients who have received phototherapy in the past 6 months, Patients with contraindication to NBUVB, Patients with known allergy to the product's excipients
Intervention groups
One group receives bFGF peptide serum and the other will only receive vehicles (both will be treated with NBUVB during the study)
Main outcome variables
Percentage of repigmentation by comparing photos taken from facial lesions

General information

Reason for update
Change in the study title (after ethics committee approval)
Acronym
IRCT registration information
IRCT registration number: IRCT20201104049265N1
Registration date: 2021-07-08, 1400/04/17
Registration timing: prospective

Last update: 2021-10-12, 1400/07/20
Update count: 1
Registration date
2021-07-08, 1400/04/17
Registrant information
Name
Seyyedeh Maryam Afshani
Name of organization / entity
Arta Zist Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 2503
Email address
m.afshani@artapharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Active Post Marketing Surveillance to Evaluate the Efficacy and Safety of bFGF in Combination with NBUVB for the Treatment of Vitiligo; A Triple-blind, Randomized, Placebo-controlled Clinical Trial
Public title
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of basic Fibroblast Growth Factor Compared to Placebo in Combination with NBUVB for the Treatment of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Male or female patients aged 18 to 65 years - Willingly signed the written informed consent form - Diagnosis of non-segmental vitiligo no longer than 5 years with symmetrical lesions except for the eyelids - Stable vitiligo for at least 6 months (no new patches, or less than 10% increase in the diameter of the existing patches for at least 6 months - Candidate for phototherapy (more than 25% body surface involvement) - Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks - Have not been receiving phototherapy during the past 6 months - Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator - Patients with general good health (except vitiligo) as judged by the Investigator
Exclusion criteria:
- Women of childbearing potential, or breastfeeding women - Diagnosis of extensive or unstable vitiligo - Patients with skin cancer or precancerous skin lesions - Patients with poliosis in > 50% of their vitiligo patches - Patients with complete facial depigmentation - Diagnosis of segmental or mixed vitiligo - Subjects whose vitiligo has not responded to phototherapy or patients who have received phototherapy in the past 6 months - Patients with contraindication to NBUVB (pemphigus, Systemic Lupus Erythematosus, cataract, Xeroderma pigmentosum, patients receiving immunosuppressants due to organ transplantation, excessive photosensitivity) - Patients with known allergy to the product's ingredients and excipients (isopropyl alcohol, propylene glycol, isopropyl myristate, and phenoxy ethanol)
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into 2 groups. Both groups will be treated equally with phototherapy (NBUVB), the intervention group will administer bFGF serum and the control group will administer the vehicle. Roller bottles are not different in appearance; Therefore, patients will not be able to distinguish the bFGF-containing roller from the vehicle. Sealedenvelope.com and has been used to create a list of random codes with block sizes of four.
Blinding (investigator's opinion)
Triple blinded
Blinding description
As the serum containing bFGF and the vehicle are completely alike in their appearance, and the method and timing of administration are the same, it is expected that both the patient and the physician are unaware of receiving bFGF or vehicle. In this study, in addition to the physician and the patients, the outcome assessor will also be blind to the assigned interventions, and therefore the study will be performed as a triple-blind phase IV clinical trial.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vahdat Eslami Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.412

Health conditions studied

1

Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Percentage of repigmentation
Timepoint
Baseline, week 6, and week 16
Method of measurement
Comparison of photos taken from lesions

Secondary outcomes

1

Description
Patients' satisfaction score
Timepoint
Baseline, week 6, and week 16
Method of measurement
Asking the patient to rate their satisfaction from a scale of 0 to 10 points

2

Description
Occurrence of any adverse reactions or adverse events
Timepoint
Throughout the study period
Method of measurement
Dairy card distribution

Intervention groups

1

Description
Intervention group: BFGF serum that is administered topically to the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM.
Category
Treatment - Drugs

2

Description
Control group: Vehicle (placebo) that is administered topically on the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Amir Houshang Ehsani
Street address
Vahdat Eslami Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0223
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Imen Vaccine Alborz
Full name of responsible person
Dr. Setayesh Sadeghi
Street address
Alborz, Nazarabad, Sepehr Industrial Town, West Bahman St., No. 110
City
Nazarabad
Province
Alborz
Postal code
1399114913
Phone
+98 26 4533 4189
Email
info@imenvaccine.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imen Vaccine Alborz
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Arta Zist Pharmed
Full name of responsible person
Dr. Setayesh Sadeghi
Position
Medical department Manager
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
West side of Sheikh Baha'i Square, Ryan Vanak Building, No. 18, 6th floor, Unit 603
City
Tehran
Province
Tehran
Postal code
1993873057
Phone
+98 21 8609 2794
Email
s.sadeghi@artapharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Houshang Ehsani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5563 0553
Email
ehsanih@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arta Zist Pharmed
Full name of responsible person
Seyyedeh Maryam Afshani
Position
Medical department supervisor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
West side of Sheikh Baha'i Square, Ryan Vanak Building, No. 18, 6th floor, Unit 603
City
Tehran
Province
Tehran
Postal code
1993873057
Phone
+98 21 8609 2794
Email
m.afshani@artapharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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