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IRCT20190210042676N8 IRCT 2020-05-31 Sina Trading Company Effect of anti-stain cream containing Ginger melasma Efficacy and safety assessment of a formulated topical cream containing Ginger for treatment of mild to moderate melasma 2020-07-05 anticipated 28 Complete https://irct.ir/trial/47002 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: volunteers enter one of two intervention groups based on the randomization list (topical cream containing Ginger or 2% hydroquinone cream).Randomization is done by random block method. According to the random block method and considering the four blocks, 7 blocks will be produced for 28patients, Blinding description: The assessor doesn't know that each volunteer uses the control or studying cream. 2-3 melasma. Intervention group: Approving a formulated topical cream containing Ginger on patient with mild to moderate melasma. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Anise Samadi
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 aniseh_samadi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Cases of mild to moderate melasma (MGSC=1& 2) General health Signing the consent form for participation in the study 18 years 50 years Both Documented allergies to components of cream Use of topical lightening products like AHA ,BHA and retinoid component within 21 days prior to the study Active skin disease at test area: rosacea, atrophy, acne and eczema Pregnancy or lactating Use of systemic corticosteroid and isotretinoin within 28 days prior to the study History of laser treatment or dermabrasion or deep facialpeels within the past 3 months L81.4 Other melanin hyperpigmentation Treatment - Drugs Intervention group: Approving a formulated topical cream containing Ginger on patient with mild to moderate melasma Modified melasma severity index. Timepoint: Before intervention, 6 and 12weeks after intervention and 3 months after stop using. Method of measurement: mMASI. Size and amount of skin spots. Timepoint: Before intervention, 6 and 12 weeks after using and 3 months after stop using. Method of measurement: Visio face. Melanin content changes. Timepoint: Before intervention,6 and 12 weeks after using and 3 months after stop using. Method of measurement: mexameter. Sina Trading Company Approved 2020-04-07 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)