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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.
- Source :
-
Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2016 Jul; Vol. 75 (1), pp. 126-34. Date of Electronic Publication: 2016 Apr 07. - Publication Year :
- 2016
-
Abstract
- Background: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC).<br />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.<br />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.<br />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.<br />Limitations: The sample size was small.<br />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.<br /> (Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6787
- Volume :
- 75
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of the American Academy of Dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 27067393
- Full Text :
- https://doi.org/10.1016/j.jaad.2016.01.050