Topical diclofenac in hyaluronan gel for the treatment of solar keratoses.
This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of a topical gel containing 3% diclofenac in 2.5% hyaluronan in 150 patients with solar keratoses (SK). The active treatment was compared with the vehicle only, hyaluronan gel, as placebo over a 12-week period. Patients in both groups applied the active treatment or placebo to a targeted area of skin (0.25 g b.d.). At 12 weeks the mean lesion-count reduction in the targeted area was not significantly different between treatments. However, at post-termination follow up (16 weeks), there was a highly significant decrease in the number of lesions, 6.2 +/- 7.5 standard deviations (SD) (56.1% reduction) in the active treatment group compared with 2.4 +/- 4.3 SD (23.6% reduction) in the placebo group (P < 0.001). Other efficacy measures (complete lesion resolution, >50% lesion reduction) were also significantly different (P < 0.01) between treatments at 16 weeks. In conclusion, topical 3% diclofenac in 2.5% hyaluronan gel was effective and well tolerated in this study, suggesting a role for this therapy in the treatment of SK.
Gebauer
Kurt
K
Fremantle Dermatology Clinic, Fremantle, Western Australia, Australia. kurt@fremderm.iinet.net.au
Brown
Pam
P
Varigos
George
G
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005782:Gels; D006229:Hand Dermatoses / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007642:Keratosis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D013472:Sunlight / Q000009:adverse effects; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D004008:Diclofenac; D006820:Hyaluronic Acid