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

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®.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNIFESP - Universidade Federal de São Paulo, São Paulo, Brazil

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...);

Treatment and study plan

Tri-Luma Maintenance regimen

Behavioral

Primary outcomes

Time to relapse during the Maintenance Phase

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Acronym: CLARA

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 12, 2007
Registry last updated: Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed