Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma (CLARA)
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®.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma|
- Time to relapse during the Maintenance Phase
- Subject's Quality of Life questionnaire (MelasQol)at the end of each treatment phase/Early termination.
|Study Start Date:||November 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||Behavioral: Tri-Luma Maintenance regimen|
|Active Comparator: 2||Behavioral: Tri-Luma Maintenance regimen|
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)
|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|