Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma (CLARA)
|ClinicalTrials.gov Identifier: NCT00500162|
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : March 6, 2009
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Active Comparator: 1||Behavioral: Tri-Luma Maintenance regimen|
|Active Comparator: 2||Behavioral: Tri-Luma Maintenance regimen|
- Time to relapse during the Maintenance Phase
- Subject's Quality of Life questionnaire (MelasQol)at the end of each treatment phase/Early termination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500162
|UNIFESP - Universidade Federal de São Paulo|
|Sao Paulo, Brazil|
|Hospital General de México - Servicio de Dermatología|
|Mexico City, Mexico|
|Principal Investigator:||Karime HASSUN, MD||UNIFESP - Universidade Federal de São Paulo|