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Comparison of Efficacy and Safety of 0.1% Tacrolimus and 0.1% Mometasone Furoate for Adult Vitiligo

NCT01333410 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-10-10

No results posted yet for this study

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.

Conditions

  • Vitiligo

Interventions

DRUG

tacrolimus ointment

2 applications per days for 6 months

DRUG

Mometasone furoate

2 applications per day for 6 months

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chanisada Wongpraparut, M.D. · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01333410 on ClinicalTrials.gov