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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333410
Recruitment Status : Unknown
Verified October 2012 by chanisada tuchinda, Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2011
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
chanisada tuchinda, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: tacrolimus ointment Drug: Mometasone furoate Phase 4

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: 0.1% tacrolimus ointment Drug: tacrolimus ointment
2 applications per days for 6 months
Other Name: protopic
Active Comparator: 0.1% mometasone furoate cream Drug: Mometasone furoate
2 applications per day for 6 months
Other Name: elomet

Primary Outcome Measures :
  1. percent of repigmentation [ Time Frame: 6 months ]

    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

Secondary Outcome Measures :
  1. side effect [ Time Frame: 6 months ]
    Possible side effect from topical 0.1% tacrolimus ointment and 0.1% mometasone furoate cream

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333410

Department of Dermatology, Faculty of Medicine Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Principal Investigator: Chanisada Wongpraparut, M.D. Faculty of Medicine Siriraj Hospital

Responsible Party: chanisada tuchinda, Assistant Professor, Mahidol University Identifier: NCT01333410     History of Changes
Other Study ID Numbers: MahidolU
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by chanisada tuchinda, Mahidol University:
mometasone furoate

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Mometasone Furoate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents