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

NCT01333410 | Unknown Phase 4 DMC

• 1 other identifier: MahidolU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitiligo; tacrolimus; mometasone furoate

Outcome Measures

Primary Outcomes (1)

• percent of repigmentation

  Percent of patients who get repigmentation of the lesion after 0.1% tacrolimus ointment VS 0.1% mometasone furoate cream Percent of repigmentation is defined as following * No improvement (0 % repigmentation) * Improved by 1-25% repigmentation * Improved by 26-50% repigmentation * Improved by 51-75% repigmentation * Improved by 76-100% repigmentation

  6 months

Secondary Outcomes (1)

• side effect

  6 months

Study Arms (2)

0.1% tacrolimus ointment

ACTIVE COMPARATOR

Drug: tacrolimus ointment

0.1% mometasone furoate cream

ACTIVE COMPARATOR

Drug: Mometasone furoate

Interventions

tacrolimus ointment DRUG

2 applications per days for 6 months

Also known as: protopic

0.1% tacrolimus ointment

Mometasone furoate DRUG

2 applications per day for 6 months

Also known as: elomet

0.1% mometasone furoate cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be above 18 years old
• Patients must have symmetrical vitiligo lesion on both sides of the body. Total vitiligo area is not exceeded 5% of the body surface area
• 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

You may not qualify if:

• Patient who have the lesion on acral area (hands or feet)
• Pregnancy or lactation patient

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Dermatology, Faculty of Medicine Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Tacrolimus; Mometasone Furoate

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chanisada Wongpraparut, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

TH (1)