Brinkhuizen, Tjinta

Frencken, Kiki J A

Hausen, Axel zur

Hoff, Marlou L S

Kelleners-Smeets, Nicole W J

Mosterd, Klara

Nelemans, Patty J.

Rennspiess, Dorit

van der Horst, Michiel P J

van Steensel, Maurice A M

Winnepenninckx, Véronique J L

Frencken, Kiki J. A.

Nelemans, Patricia

Hoff, Marlou L. S.

Kelleners-Smeets, Nicole W. J.

zur Hausen, Axel

van der Horst, Michiel P. J.

Winnepenninckx, Veronique J. L.

van Steensel, Maurice A. M.

NARCIS 

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

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 &lt;.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

Maastricht University Research Portal

Tjinta Brinkhuizen

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

Crossref

Journal of the American Academy of Dermatology

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

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 &lt;.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.</p

Discovery Research Portal

English

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

https://discovery.dundee.ac.uk/files/8898842/Manuscript_Revised_JAAD_D_15_01227R3_final_short_version.pdf

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

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Maastricht University Research Portal

Maastricht University Research Portal

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Discovery Research Portal

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