Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melasma
Intervention: Tri-Luma Maintenance regimen (Behavioral)
Phase: Phase 4
Status: Recruiting
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Karime HASSUN, MD, Principal Investigator, Affiliation: UNIFESP – Universidade Federal de São Paulo
Overall contact:
Geraldine THOMAS, Phone: 33.4.93.95.70.42, Email: geraldine.thomas@galderma.com
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®.
Clinical Details
Official title: Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to relapse during the Maintenance Phase
Secondary outcome: Subject’s Quality of Life questionnaire (MelasQol)at the end of each treatment phase/Early termination.
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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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...);
Locations and Contacts
Geraldine THOMAS, Phone: 33.4.93.95.70.42, Email: geraldine.thomas@galderma.com
UNIFESP – Universidade Federal de São Paulo, SAO PAULO, Brazil; Not yet recruiting
KARIME HASSUN, MD, Phone: +55 11 5572 7670, Email: karime.uniderma@saudetotal.com
Karime Hassun, MD, Principal Investigator
Hospital General de México - Servicio de Dermatología, Mexico City, Mexico; Recruiting
Ivonne ARELLANO, MD, Phone: +525 5 5999 6136, Ext: 1055, Email: mariare1@yahoo.com
Additional Information
Starting date: November 2006
Ending date: July 2007
Last updated: July 23, 2007
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