Comparison of topical 3% diclofenac sodium gel and 5% imiquimod cream for the treatment of actinic keratoses

Clin Exp Dermatol. 2011 Jul;36(5):479-84. doi: 10.1111/j.1365-2230.2010.03999.x. Epub 2011 Mar 21.


Background: There is a wide spectrum of treatments available for actinic keratosis (AK). Topical diclofenac sodium and imiquimod are two topical treatments, which are noninvasive, easily applied, well-tolerated and effective.

Aim: To compare the effects of topical 3% diclofenac sodium plus hyaluranon (DFS) gel, 5% imiquimod (IMQ) cream, and base cream (BC) in patients with AK.

Methods: In total, 61 patients, diagnosed clinically and histopathologically as having AK, were randomized into three treatment groups to receive topical treatment with either DFS (twice daily for 12 weeks), IMQ (twice per week for 16 weeks) or BC (twice daily for 12 weeks). Patients were evaluated clinically at 0, 4, 8, 12, 16, 20 and 24 weeks. Treatment efficacy was assessed by Total Thickness Score (TTS) and Patient Global Improvement Index (PGII).

Results: Complete clearance rates for DFS, IMQ and BC at the end of the treatment and at the end of the total follow-up period were 19.1%, 20% and 0%, and 14.3%, 45% and 0%, respectively. Although the average TTS value of the DFS group at week 24 was significantly higher than that of the IMQ group, the PGII values were not significantly different.

Conclusions: Although DFS and IMQ each had considerable efficacy in the treatment of AK, the efficacy of DFS seemed to decrease after cessation of treatment.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Aged, 80 and over
  • Aminoquinolines / administration & dosage
  • Aminoquinolines / therapeutic use*
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Diclofenac / administration & dosage
  • Diclofenac / therapeutic use*
  • Female
  • Gels
  • Humans
  • Imiquimod
  • Keratosis, Actinic / drug therapy*
  • Keratosis, Actinic / pathology
  • Male
  • Middle Aged
  • Ointments
  • Single-Blind Method
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Treatment Outcome


  • Aminoquinolines
  • Anti-Inflammatory Agents, Non-Steroidal
  • Antineoplastic Agents
  • Gels
  • Ointments
  • Diclofenac
  • Imiquimod