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IRCT20161207031288N6 IRCT 2020-10-12 Tehran University of Medical Sciences Assessment of pomegranate whitening cream on melasma consideration of clinical safety and efficacy of topical formulation of polyphenolic extract of punica granatum on patients with mild to moderate forms of melasma 2020-10-22 anticipated 20 Complete https://irct.ir/trial/50039 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Melasma. Intervention group: Approving the whitening cream on patient with mild to moderate melasma (single arm study). Yes - There is a plan to make this available What will be shared: Whole data is publishable after making patients identity unrecognisable When: Beginning of access to data would be six months after publishing of data To whom: Academic researchers Conditions: Any sort of application of data is allowed, except using for making medicine based on the research Where to obtain: For accessing data refer to Dr. Mahdi Vazirian. Address: Faculty of Pharmacy, In fron ot Nosrat Ave., 16th Azar Ave., Keshavarz Blvd., Tehran, Iran. How to obtain: Sending an E. mail request (mehdivazirian@gmail.com) or in-person referring to mentioned address. Data would be presentable within one week after request. Comments:
public Saman Ahmad Nasrollahi
415 Taleqani Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 snasrollahi@tums.ac.ir Center For Research And Training In Skin Diseases And Leprosy scientific Alireza firooz
No. 415, Taleqni Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Mild to moderate melasma with minimum grade of Melasma area and severity index = 1 Age range 18-50 Signing consent form, voluntarily and knowingly 18 years 50 years Both Pregnancy or lactation Using oral corticosteroids or isotretinoin within 28 days prior to the study Any active skin disease at test area including rosacea, eczema, atrophy, acne Using any light sensitizing medicine within 3 months prior to the study Use of topical lightening products like alpha hydroxy acid, beta hydroxy acid, and retinoid component within 21 days prior to the study Documented allergy to components of the cream History of laser treatment or dermabrasion or deep facial peeling within the past 3 months prior to the study Using contraceptive or hormonal medicines L81.1 Chloasma Treatment - Drugs Intervention group: Approving the whitening cream on patient with mild to moderate melasma (single arm study) Modified melasma severity index. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: Modified Melasma Area and Severity Index. Skin pH. Timepoint: At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention. Method of measurement: Cutometer MPA 580. Skin sebum. Timepoint: At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention. Method of measurement: Cutometer MPA 580. Skin melanin and erythem. Timepoint: At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention. Method of measurement: Cutometer MPA 580. Transepidermal watre loss. Timepoint: At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention. Method of measurement: Cutometer MPA 580. Size and value of skin spot. Timepoint: At the beginning (before start of the intervention) and 4 and 8 weeks after start of the intervention. Method of measurement: Visio face device. Tehran University of Medical Sciences Approved 2019-12-31 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)