A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma.
BACKGROUND
Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge.


OBJECTIVE
To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0.01%, hydroquinone (HQ) 4%, tretinoin 0.05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients.


METHODS
This was a multicentre, randomized, controlled, investigator-blinded, parallel comparison study. East and South-East Asian patients aged 18 years or older, with a clinical diagnosis of moderate to severe melasma, were enrolled in this study. Patients were enrolled at baseline and treated daily for 8 weeks with TC cream (one application at bedtime) or HQ cream (twice daily). There were four study visits: at baseline and weeks 2, 4 and 8. The primary efficacy variable was the melasma global severity score (GSS). Other outcome measures included Melasma Area and Severity Index, global improvement and patient satisfaction. Safety was assessed through the reporting of adverse events.


RESULTS
TC had superior efficacy to HQ for the primary variable: 77/120 patients (64.2%) on TC had GSS 'none' or 'mild' at week 8 vs. 48/122 patients (39.4%) on HQ (P < 0.001). The secondary efficacy variables confirmed these results. Patient satisfaction was in favour of TC (90/127, 70.8%, vs. 64/129, 49.6%; P = 0.005). More patients had related adverse events on TC (63/129, 48.8%) than on HQ (18/131, 13.7%) but most were mild and none was severe.


CONCLUSIONS
Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.
Chan
R
R
National Skin Centre, 1 Mandalay Road, Singapore 308205. roychan@nsc.gov.sg
Park
K C
KC
Lee
M H
MH
Lee
E-S
ES
Chang
S E
SE
Leow
Y H
YH
Tay
Y-K
YK
Legarda-Montinola
F
F
Tsai
R-Y
RY
Tsai
T-H
TH
Shek
S
S
Kerrouche
N
N
Thomas
G
G
Verallo-Rowell
V
V
D000279:Administration, Cutaneous; D000328:Adult; D000704:Analysis of Variance; D044466:Asian People; D004311:Double-Blind Method; D004338:Drug Combinations; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage*; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage*; D008297:Male; D008548:Melanosis / Q000188:drug therapy* / Q000208:ethnology / Q000523:psychology; D008875:Middle Aged; D009824:Ointments; D017060:Patient Satisfaction; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage*
D004338:Drug Combinations; D006873:Hydroquinones; D009824:Ointments; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone