BACKGROUND:Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS:Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.
RCT Entities:
BACKGROUND: Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS: Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.