NCT00500162

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

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)

Conditions

• Melasma

Interventions

Type	Name	Description
BEHAVIORAL	Tri-Luma Maintenance regimen

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-07-12
• Last updated: 2021-02-17

Locations

2 sites across 2 countries: Brazil, Mexico