1. 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.
- Author
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Brinkhuizen T, Frencken KJ, Nelemans PJ, Hoff ML, Kelleners-Smeets NW, Zur Hausen A, van der Horst MP, Rennspiess D, Winnepenninckx VJ, van Steensel MA, and Mosterd K
- Subjects
- Administration, Topical, Aged, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Apoptosis drug effects, Calcitriol administration & dosage, Calcitriol adverse effects, Carcinoma, Basal Cell chemistry, Carcinoma, Basal Cell pathology, Cell Proliferation drug effects, Diclofenac administration & dosage, Diclofenac adverse effects, Drug Therapy, Combination, Female, Gels, Humans, Ki-67 Antigen analysis, Male, Medication Adherence, Middle Aged, Ointments, Proto-Oncogene Proteins c-bcl-2 analysis, Single-Blind Method, Skin Neoplasms chemistry, Skin Neoplasms pathology, Treatment Outcome, Vitamins administration & dosage, Vitamins adverse effects, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Calcitriol therapeutic use, Carcinoma, Basal Cell drug therapy, Diclofenac therapeutic use, Skin Neoplasms drug therapy, Vitamins therapeutic use
- 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., (Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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