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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00500162
First received: July 11, 2007
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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®.


Condition Intervention Phase
Melasma
Behavioral: Tri-Luma Maintenance regimen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Time to relapse during the Maintenance Phase

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

Enrollment: 340
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Behavioral: Tri-Luma Maintenance regimen
Active Comparator: 2 Behavioral: Tri-Luma Maintenance regimen

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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...);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500162

Locations
Brazil
UNIFESP - Universidade Federal de São Paulo
Sao Paulo, Brazil
Mexico
Hospital General de México - Servicio de Dermatología
Mexico City, Mexico
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Karime HASSUN, MD UNIFESP - Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Gladerma, Galderma
ClinicalTrials.gov Identifier: NCT00500162     History of Changes
Other Study ID Numbers: RD.03.SPR.29059
Study First Received: July 11, 2007
Last Updated: March 5, 2009
Health Authority: Mexico: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

ClinicalTrials.gov processed this record on October 21, 2014