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

Tjinta Brinkhuizen (Lead / Corresponding author), Kiki J A Frencken, Patty J. Nelemans, Marlou L S Hoff, Nicole W J Kelleners-Smeets, Axel zur Hausen, Michiel P J van der Horst, Dorit Rennspiess, Véronique J L Winnepenninckx, Maurice A M van Steensel, Klara Mosterd

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    Abstract

    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 μg/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
    Number of pages9
    JournalJournal of the American Academy of Dermatology
    Volume75
    Issue number1
    Early online date7 Apr 2016
    DOIs
    Publication statusPublished - Jul 2016

    Keywords

    • Basal cell carcinoma
    • Calcitriol
    • Diclofenac
    • Noninvasive
    • Nonsteroidal anti-inflammatory drugs
    • Targeted therapy
    • Topical
    • Vitamin D

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