Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma.
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.


CONCLUSIONS
This was an open-label trial.


CONCLUSIONS
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.
Grimes
Pearl E
PE
Division of Dermatology, University of California, Los Angeles, California, USA.
Bhawan
Jag
J
Guevara
Ian L
IL
Colón
Luz E
LE
Johnson
Lori A
LA
Gottschalk
Ronald W
RW
Pandya
Amit G
AG
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008548:Melanosis / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D009824:Ointments; D012880:Skin Pigmentation; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D004338:Drug Combinations; D006873:Hydroquinones; D009824:Ointments; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone