Comparison of Efficacy and Safety of 0.1% Tacrolimus and 0.1% Mometasone Furoate for Adult Vitiligo
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|ClinicalTrials.gov 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
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|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
U.S. FDA Resources
|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
- 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
- side effect [ Time Frame: 6 months ]Possible side effect from topical 0.1% tacrolimus ointment and 0.1% mometasone furoate cream
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 ClinicalTrials.gov identifier (NCT number): NCT01333410
|Department of Dermatology, Faculty of Medicine Siriraj Hospital|
|Principal Investigator:||Chanisada Wongpraparut, M.D.||Faculty of Medicine Siriraj Hospital|