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IRCT20180910040994N1 IRCT 2019-08-05 Islamic Azad University Effect of Turmeic in treatment of Vitiligo Evaluation of local effects of Turmeric drug in improvement of lesions in patients with vitiligo in comparison to placebo 2018-09-23 anticipated 30 Complete https://irct.ir/trial/33768 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: pilot study, Randomization description: In this study, simple randomization method is used in left and right subgroups in which one side is always for drug and the other side is always for placebo. A package is given to patients containing 2 creams, including turmeric cream and placebo. The placebo is devoid of the active ingredient of Curcumin and is otherwise similar to the drug. These two creams is labeled with right and left by a third person that the information about them is only available to that person and the investigator, patient and observer dermatologist are not aware of the content of the creams. The patient should apply the creams twice a day at the specified side for four months, Blinding description: Patient , researcher and the observer dermatologist of the study are all blinded to the randomization state in the investigation. In addition , evaluation of the efficacy of the drug will be scored by 2 blinded dermatologists by comparing before and after treatment photos at the end of the study. 3 vitiligo. Intervention 1: Intervention group: Turmeric cream 5% produced by Seagull Laboratory will be used on the lesions, twice a day, for 4 months. Intervention 2: Control group: Moisturizing cream containing yellow color with cosmetic grade will be used on the lesions, twice a day, for 4 months. 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 We only supply the detail for publication purpose only , the patient's personal data will not be supplied.
public Mehdi Rajabi
Islamic Azad University Of Pharmaceutical Sciences , Yakhchal St. , Shariati St. , Tehran
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 mehdirj@aol.co.uk Islamic Azad University scientific Parvin Mansouri
Second floor , Shooan building , Sheybani Alley , North Kamraniyeh
Tehran Iran (Islamic Republic of) 1978854321 +98 21 2615 1500 mansorip@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Suffering from vitiligo Stability of lesions for at least 3 months Less than 20 percent of skin involvement Having symmetrical lesions 8 years 65 years Both Generalized or progressive vitiligo pregnancy or lactation any history of allergy to Curcumin patients who are resistant to other vitiligo therapies such as immunomodulators drugs , photo-therapy and etc. any malignancy or active skin infections L80 Vitiligo Treatment - Drugs Placebo Intervention group: Turmeric cream 5% produced by Seagull Laboratory will be used on the lesions, twice a day, for 4 months. Control group: Moisturizing cream containing yellow color with cosmetic grade will be used on the lesions, twice a day, for 4 months. Size of lesions. Timepoint: at baseline and 1,2,3 and 4 months after using the drug. Method of measurement: imagej application. Notice ability of lesions. Timepoint: at the end of the study. Method of measurement: Vitiligo Noticeability Scale Questionnaire. Percentage of re-pigmentation. Timepoint: at baseline and 1,2,3 and 4 months after using the drug. Method of measurement: taking photo under wood lamp. Quality of life score in patients with vitiligo. Timepoint: before initiation of treatment and after finishing it. Method of measurement: Vitiligo Quality of Life Questionnaire. Islamic Azad University Approved 2019-03-11 Ethics committee of Tehran branch, Islamic Azad University of Medical Sciences Tehran branch, Islamic Azad University of Medical Sciences, Khaghani Street, Shariati Street Tehran Tehran Iran (Islamic Republic of)