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IRCT20220117053743N2 IRCT 2022-05-09 Esfahan University of Medical Sciences Comparison of the therapeutic effects of four topical drugs in the treatment of vitiligo Comparison of the therapeutic effects of four topical drugs on patients with vitiligo referred to the dermatological clinics of Isfahan University of Medical Sciences 2022-03-06 anticipated 60 Complete https://irct.ir/trial/62528 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 60 unclear envelopes and 60 cards with the names of the groups (A, B, C, D) will be prepared (15 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A, B, C, or D based on the card inside the selected envelope, Blinding description: The topical drugs will be prepared by the personnel of a pharmaceutical company uninvolved in the study in four tubes of similar shape and color labeled A, B, C, and D. One tube will be delivered to each patient by the investigator based on their group. Thus, the participants, the investigator, the assessor, and even the data analyzer will be unaware of the drug received by the patients. 3 Vitiligo. Intervention 1: Intervention group: clobetasol 0.05% (Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure. Intervention 2: Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% + methoxsalen 0.01% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure. Intervention 3: Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% + methoxsalen 0.005% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure. Intervention 4: Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Aida Farmani
Dermatology department, Alzahra Hospital, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3261 6408 aida.farmani.med@gmail.com Esfahan University of Medical Sciences scientific Aida Farmani
Dermatology department, Alzahra hospital, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3261 6408 aida.farmani.med@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 16-60 years Involvement of <20% total body surface area Lesions on the extremities, trunk, and face 16 years 60 years Both Follicular pigmentation White hair in the lesion Lesions at the distal end of the extremities Genital, periungual, and skin fold lesions Topical treatment or phototherpay within the past month Pregnancy L80 Vitiligo Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: clobetasol 0.05% (Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% + methoxsalen 0.01% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% + methoxsalen 0.005% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure Intervention group: clobetasol 0.05% + propylene glycol 5% + aspirin 1% + copper sulfate 0.1% (all medication from Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure Perifollicular pigmentation improvement. Timepoint: Three months after the initiation of treatments. Method of measurement: 1) mild: 0-25%, 2) moderate: 26-50%, 3) good: 50-75%, 4) excellent: >75%. Patient satisfaction with treatments. Timepoint: Three months after the initiation of treatments. Method of measurement: Visual Analogue Scale. Side effects. Timepoint: During treatments. Method of measurement: Patient reports of observation by the specialist. Esfahan University of Medical Sciences Approved 2022-04-11 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)