Comparison of the therapeutic effects of four topical drugs on patients with vitiligo referred to the dermatological clinics of Isfahan University of Medical Sciences
Comparison of safety and efficacy of 4 topical drugs of clobetasol, clobetasol + propylene glycol + aspirin + copper sulfate + methoxsalen 0.01%, clobetasol + propylene glycol + aspirin + copper sulfate + methoxsalen 0.005%, and clobetasol + propylene glycol + aspirin + copper sulfate in the treatment of vitiligo
Design
Phase III four-arm triple-blind randomized trial with parallel groups on 60 patients, randomization will be performed by sealed envelopes.
Settings and conduct
This study will include 60 patients with vitiligo referred to the dermatology clinic of Sedighe Tahere Hospital, Isfahan. The patients will be randomized into 4 groups. The participants, the investigator, the assessor, and even the data analyzer will be unaware of the drug received by the patients.
Application of cream will be daily and left for at least 3 hours on the skin while avoiding direct sun exposure. Perifollicular pigmentation will be evaluated at the beginning and 3 months since the initiation of treatments and patient satisfaction only 3 months after.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 16-60 years
Lesions of the extremities, trunk, and face
Exclusion criteria:
Follicular pigmentation
White hair in the lesion
Lesions at the distal end of the extremities
Genital, periungual, or skin fold lesions
Topical treatment or phototherapy within the past month
Pregnancy
Comparison of the therapeutic effects of four topical drugs on patients with vitiligo referred to the dermatological clinics of Isfahan University of Medical Sciences
Public title
Comparison of the therapeutic effects of four topical drugs in the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 16-60 years
Involvement of <20% total body surface area
Lesions on the extremities, trunk, and face
Exclusion criteria:
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
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan, Iran
Intervention group: clobetasol 0.5% (Raha Pharmaceutical Co., Iran) daily on the lesions remaining for at least 3 hours while avoiding direct sun exposure
Category
Treatment - Drugs
2
Description
Intervention group: clobetasol 0.5% + 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
Category
Treatment - Drugs
3
Description
Intervention group: clobetasol 0.5% + 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
Category
Treatment - Drugs
4
Description
Intervention group: clobetasol 0.5% + 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