Comparison of the efficacy and tolerability of 3% diclofenac sodium gel and 5% imiquimod cream in the treatment of actinic keratosis.
BACKGROUND
Topical diclofenac and imiquimod have been reported to be effective in the treatment of actinic keratosis, but a study to compare these two drugs has not been reported yet.


OBJECTIVE
To compare the efficacy and safety of topical 3% diclofenac gel plus hyaluronic acid and 5% imiquimod cream in the treatment of actinic keratosis.


METHODS
Forty-nine patients with actinic keratosis were enrolled in this randomized comparative open-label study. Twenty-four patients applied 3% diclofenac gel once a daily to their lesions, while the other 25 patients were treated with a 5% imiquimod cream three times a week for 12 weeks. Patients were examined before treatment and every month of the treatment. Assessments were made by investigators according to the Investigator and the Patient Global Improvement Indices (IGII) and (PGII).


RESULTS
According to the IGII results, a complete response was observed in 12% of the diclofenac group and 22% of the imiquimod group. For the PGII scores, a complete response was observed in 28% of the diclofenac group and 23% of the imiquimod group. There were no significant differences between the two groups (p > 0.05). Both treatments were well tolerated, with most adverse events related to skin.


CONCLUSIONS
The two drugs were found to be equally effective and safe in the treatment of actinic keratosis but complete remission was very low. Therefore, topical treatments with these two drugs were not seen to be completely effective, and combined therapies and further studies are needed.
Kose
Osman
O
Department of Dermatology, Gulhane School of Medicine, Ankara, Turkey. okose@gata.edu.tr
Koc
Erol
E
Erbil
A Hakan
AH
Caliskan
Ercan
E
Kurumlu
Zafer
Z
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005145:Face / Q000473:pathology; D005260:Female; D005782:Gels; D006801:Humans; D000077271:Imiquimod; D007642:Keratosis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D016896:Treatment Outcome; D014466:Ultraviolet Rays / Q000009:adverse effects
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D004008:Diclofenac; D000077271:Imiquimod