Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma (CLARA)

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: NCT00500162
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : March 6, 2009
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Brief Summary:

Melasma is an acquired, symmetric, irregular hypermelanosis on sun-exposed areas of the face, commonly seen in Latin American women. It is a very frequent disease, although its true incidence is unknown.

Melasma has historically been difficult to treat and therapy remains a challenge for this chronic condition.

Melasma being a relapsing disease, there is a real need to address how to maintain efficacy achieved after acute treatment. A previous 12-month trial has shown that Tri-Luma® applied once daily over a long-term period is safe and tolerable. However, there are no robust data available either on the efficacy of Tri-Luma® in long-term treatment or guidance for a maintenance dosage regimen with this product.

Investigations have been made through a feasibility work among Dermatologists from USA and Latin America to assess their current practice in terms of Maintenance Therapy. Two regimens appear to be prescribed frequently and will be compared in this study.

The expectation is that Tri-Luma® will be effective, in one of the two regimens explored, in maintaining the Melasma improvement achieved with a previous treatment of Tri-Luma®.

Condition or disease Intervention/treatment Phase
Melasma Behavioral: Tri-Luma Maintenance regimen Phase 4

Detailed Description:
This study will last 32 weeks (8 months) as a maximum. 11 visits will take place (Last visit of Initial Treatment Phase = Baseline of Maintenance Phase) Initial Treatment Phase : Visit 1 (Baseline), 2 (Week 2), 3 (Week 4), 4 (Week 6), 5 (Week 8), Maintenance Phase : Visit 1 (Baseline), 2 (Week 4), 3 (Week 8), 4 (Week 12), 5 (Week 16), 6 (Week 20) , 7 (Week 24)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma
Study Start Date : November 2006
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tri-luma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Behavioral: Tri-Luma Maintenance regimen
Active Comparator: 2 Behavioral: Tri-Luma Maintenance regimen

Primary Outcome Measures :
  1. Time to relapse during the Maintenance Phase

Secondary Outcome Measures :
  1. Subject's Quality of Life questionnaire (MelasQol)at the end of each treatment phase/Early termination.

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:

  • Subjects with a clinical diagnosis of moderate to severe Melasma
  • Subjects with a Fitzpatrick skin type between I and V

Exclusion Criteria:

  • Female subjects who are pregnant or planning a pregnancy during the study;
  • Subjects with a wash-out period for topical treatments on the treated areas less than 2 weeks for corticosteroids, glycolic Acid (in daily care cream, Bleaching products, UV light therapy and sunbathing, Topical retinoids including retinol, and less than 3 months for Lasers, IPL, dermabrasion, peeling
  • Subjects with a wash-out period for systemic treatments less than 1 month for Corticosteroids and hormone-replacement therapies (unless subjects have been on treatment for at least 3 months)
  • Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...);

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): NCT00500162

UNIFESP - Universidade Federal de São Paulo
Sao Paulo, Brazil
Hospital General de México - Servicio de Dermatología
Mexico City, Mexico
Sponsors and Collaborators
Principal Investigator: Karime HASSUN, MD UNIFESP - Universidade Federal de São Paulo

Responsible Party: Gladerma, Galderma Identifier: NCT00500162     History of Changes
Other Study ID Numbers: RD.03.SPR.29059
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases