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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
chanisada tuchinda, Mahidol University
ClinicalTrials.gov Identifier:
NCT01333410
First received: April 8, 2011
Last updated: October 7, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Vitiligo
Drug: tacrolimus ointment
Drug: Mometasone furoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • percent of repigmentation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • side effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Possible side effect from topical 0.1% tacrolimus ointment and 0.1% mometasone furoate cream


Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333410

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

No publications provided

Responsible Party: chanisada tuchinda, Assistant Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01333410     History of Changes
Other Study ID Numbers: MahidolU
Study First Received: April 8, 2011
Last Updated: October 7, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
vitiligo
tacrolimus
mometasone furoate

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Mometasone furoate
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014