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

NCT00500162 | Completed Phase 4

• 1 other identifier: RD.03.SPR.29059
• Study Type: interventional
• Target: 340
• Locations: 2 countries
• Sites: 2

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®.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Time to relapse during the Maintenance Phase

Secondary Outcomes (1)

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

Study Arms (2)

1

ACTIVE COMPARATOR

Behavioral: Tri-Luma Maintenance regimen

2

ACTIVE COMPARATOR

Behavioral: Tri-Luma Maintenance regimen

Interventions

Tri-Luma Maintenance regimen BEHAVIORAL

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a clinical diagnosis of moderate to severe Melasma
• Subjects with a Fitzpatrick skin type between I and V

You may not qualify if:

• 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...);

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

UNIFESP - Universidade Federal de São Paulo

São Paulo, Brazil

Location

Hospital General de México - Servicio de Dermatología

Mexico City, Mexico

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Karime HASSUN, MD

  UNIFESP - Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 12, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 17, 2021

Record last verified: 2009-03

Locations

BR (1); ME (1)