The effect of topical diclofenac 3% and calcitriol 3 mg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial

Tjinta Brinkhuizen*, Kiki J. A. Frencken, Patricia Nelemans, Marlou L. S. Hoff, Nicole W. J. Kelleners-Smeets, Axel zur Hausen, Michiel P. J. van der Horst, Dorit Rennspiess, Veronique J. L. Winnepenninckx, Maurice A. M. van Steensel, Klara Mosterd

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

25 Citations (Web of Science)


Background: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). Objective: We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 mu g/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. Methods: Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group). After self-application twice daily under occlusion (8 weeks), tumors were excised. Primary outcome was posttreatment expression levels of proliferation (Ki-67) and antiapoptosis (B-cell lymphoma [Bcl-2]) immunohistochemical markers. Secondary outcomes were histologic clearance, adverse events, application-site reactions, and patient compliance. Results: sBCC treated with diclofenac showed a significant decrease in Ki-67 (P <.001) and Bcl-2 (P = .001), and after combination therapy for Ki-67 (P = .012). Complete histologic tumor regression was seen in 64.3% (P = .0003) of sBCC (diclofenac) and 43.8% (P = .007) of sBCC (combination therapy) compared with 0.0% of controls. No significant changes were found in nodular BCC. Application-site reactions were mostly mild to moderate. Limitations: The sample size was small. Conclusion: Our results suggest that topical diclofenac is a promising new treatment for sBCC. Its mode of action differs from available noninvasive therapies, and thus has an additive value.
Original languageEnglish
Pages (from-to)126-134
JournalJournal of the American Academy of Dermatology
Issue number1
Publication statusPublished - Jul 2016


  • basal cell carcinoma
  • calcitriol
  • diclofenac
  • noninvasive
  • nonsteroidal anti-inflammatory drugs
  • targeted therapy
  • topical
  • vitamin D

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