Overview

This trial is active, not recruiting.

Condition vitiligo
Treatments tacrolimus ointment, mometasone furoate
Phase phase 4
Sponsor Mahidol University
Start date June 2009
End date June 2013
Trial size 30 participants
Trial identifier NCT01333410, MahidolU

Summary

Vitiligo has remained a difficult disease to treat. Previous available therapies are often ineffective. It usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. The desire of the patient to undergo therapy varies from patient to patient and needs to be assessed individually. Several factors should be considered when planning the treatment strategies including type of vitiligo, site and degree of involvement, skin color, psychological effect, patient compliance, ease to assess to therapy, cost of treatment and social association of the disease.

Topical corticosteroids are still be the standard treatment of localized vitiligo. However, the adverse effects such as skin atrophy, striae, pigmentary change and hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of topical steroids for a long period of time.

Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell activation and cytokine release. It offers a safe and efficacious alternative for many skin conditions. It minimizes the need for topical glucocorticoids and does not cause skin atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of melanocytes and melanoblasts.

This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
tacrolimus ointment protopic
2 applications per days for 6 months
(Active Comparator)
mometasone furoate elomet
2 applications per day for 6 months

Primary Outcomes

Measure
percent of repigmentation
time frame: 6 months

Secondary Outcomes

Measure
side effect
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients must be above 18 years old 2. Patients must have symmetrical vitiligo lesion on both sides of the body. Total vitiligo area is not exceeded 5% of the body surface area 3. Discontinue any previous systemic medication or phototherapy for at least 3 months and discontinue any topical medication for at least 1 month before starting the study Exclusion Criteria: 1. Patient who have the lesion on acral area (hands or feet) 2. Pregnancy or lactation patient

Additional Information

Official title Comparison the Efficacy and Safety of 0.1% Tacrolimus Ointment With 0.1% Mometasone Furoate Cream in the Treatment of Adult Vitiligo: A Single Blinded Pilot Study
Principal investigator Chanisada Wongpraparut, M.D.
Description At first visit, patients will be randomized to receive 0.1% tacrolimus ointment for apply to vitiligo lesion on one side of the body. The lesion on the other side of the body will be treated with 0.1% mometasone furoate cream. Patients are instructed to apply 0.1% tacrolimus ointment and 0.1% mometasone furoate cream twice a day for 6 months Patients will be follow up at 2, 4 and 6 months for clinical improvement, side effects and photographs
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Mahidol University.