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

NCT ID: NCT00500162

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-10-31

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®.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Tri-Luma Maintenance regimen

Intervention Type: BEHAVIORAL

2

Group Type: ACTIVE_COMPARATOR

Tri-Luma Maintenance regimen

Intervention Type: BEHAVIORAL

Interventions

Tri-Luma Maintenance regimen

Intervention Type: BEHAVIORAL

Eligibility Criteria

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...);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Galderma

Principal Investigators

Karime HASSUN, MD

Role: PRINCIPAL_INVESTIGATOR

UNIFESP - Universidade Federal de São Paulo

Locations

UNIFESP - Universidade Federal de São Paulo

São Paulo, , Brazil

Hospital General de México - Servicio de Dermatología

Mexico City, , Mexico

Countries

Brazil; Mexico

Other Identifiers

RD.03.SPR.29059

Identifier Type: -

Identifier Source: org_study_id