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

Melasma Clinical Trial

— CLARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500162
• Other study ID #: RD.03.SPR.29059
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: October 2008

Study information

• Verified date: March 2009
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...);

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Behavioral:
• Tri-Luma Maintenance regimen

Locations

Country	Name	City	State
Brazil	UNIFESP - Universidade Federal de São Paulo	Sao Paulo
Mexico	Hospital General de México - Servicio de Dermatología	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse during the Maintenance Phase
Secondary	Subject's Quality of Life questionnaire (MelasQol)at the end of each treatment phase/Early termination.