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Journal of the American Academy of Dermatology
Volume 62, n° 6
pages 962-967 (juin 2010)
Doi : 10.1016/j.jaad.2009.06.067
accepted : 3 June 2009
Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma
 

Pearl E. Grimes, MD a, Jag Bhawan, MD b, Ian L. Guevara, MD c, Luz E. Colón, MS d, Lori A. Johnson, PhD d, Ronald W. Gottschalk, MD, FRCPC d, Amit G. Pandya, MD c,
a Division of Dermatology, University of California, Los Angeles, California 
b Department of Dermatology, Boston University School of Medicine, Boston, Massachusetts 
c Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas 
d Galderma Laboratories, Fort Worth, Texas 

Correspondence to: Amit G. Pandya, MD, Department of Dermatology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9190.
Abstract
Background

Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effective and approved treatment for melasma.

Objective

We sought to determine the efficacy and safety of continuous therapy followed by a maintenance treatment regimen during a period of 24 weeks with a TC cream containing hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%.

Methods

Seventy patients with melasma were treated with a TC cream daily for 12 weeks, after which, if clear or almost clear, they applied the cream twice per week for 12 more weeks. For patients who were not clear or almost clear after 12 weeks, daily treatment was continued.

Results

In all, 25 patients completing the study per protocol were treated daily for 24 weeks (cohort A); 6 patients were treated daily for 12 weeks followed by 12 weeks of maintenance therapy (cohort B); and 21 patients were treated daily for 12 weeks, relapsed during the maintenance phase, and returned to daily dosing (cohort C). Pigmentation was significantly reduced at weeks 12 and 24 and global melasma severity improved at week 24 in cohorts A and C compared with baseline. Adverse events occurred in 53% of patients and were primarily mild in severity.

Limitations

This was an open-label trial.

Conclusion

About half of patients treated with a TC cream for melasma were able to begin maintenance therapy twice per week after 12 weeks; however, relapses occurred in most of these patients, requiring resumption of daily therapy. The cream is safe in the treatment of moderate to severe melasma for up to 24 weeks when used intermittently or continuously. Significant reductions in melasma severity scores were seen at weeks 12 and 24 when compared with baseline scores in all evaluable study groups

The full text of this article is available in PDF format.

Key words : hydroquinone, melasma, pigmentation, tretinoin



 Supported by Galderma Laboratories. Clinicaltrials.gov number: NCT00469183.
 Disclosure: Drs Grimes, Bhawan, and Pandya are consultants for Galderma Laboratories and have received funding to perform this study from Galderma Laboratories. Ms Colón, Dr Johnson, and Dr Gottschalk are employees of Galderma Laboratories. Dr Guevara has no conflicts of interest to declare.
 Reprints not available from the authors.



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