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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00500162
Other study ID # RD.03.SPR.29059
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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...);

Study Design


Related Conditions & MeSH terms


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.
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