Solasodine glycoalkaloids: a novel topical therapy for basal cell carcinoma. A double-blind, randomized, placebo-controlled, parallel group, multicenter study
Version of Record online: 17 DEC 2007
International Journal of Dermatology
Volume 47, Issue 1, pages 78–82, January 2008
How to Cite
Punjabi, S., Cook, L. J., Kersey, P., Marks, R. and Cerio, R. (2008), Solasodine glycoalkaloids: a novel topical therapy for basal cell carcinoma. A double-blind, randomized, placebo-controlled, parallel group, multicenter study. International Journal of Dermatology, 47: 78–82. doi: 10.1111/j.1365-4632.2007.03363.x
- Issue online: 17 DEC 2007
- Version of Record online: 17 DEC 2007
Objective To assess the safety and efficacy of a 0.005% mixture of solasodine glycosides (Zycure) in the treatment of basal cell carcinoma.
Design Double-blind, randomized, and vehicle-controlled, parallel group study.
Setting Ten centers in the United Kingdom.
Participants Male, n = 50; female, n = 44; age range, 32–95 years (Table 1).
|Zycure n = 62||Vehicle n = 32|
|Age (in years): mean||68.9||70.0|
Intervention Ninety-four patients were randomized on a 2 : 1 ratio (n = 62, Zycure; n = 32, vehicle). Histologically confirmed lesions were treated double blinded, twice daily under occlusion with Zycure or vehicle for 8 weeks. Patients were reviewed fortnightly for adverse effects and overall response. Successfully treated patients were followed up at six-month intervals for a year.
Main outcome measures The primary efficacy endpoint was histologically confirmed clearance of the basal cell carcinoma (2-mm punch biopsy) at the end of 8-week treatment.
Results Efficacy (intention-to-treat population) at 8 weeks was 66% (41/62) in the Zycure group, compared to 25% (8/32) in the vehicle group (P < 0.001; Cochran–Mantel–Haenszel test). Ninety percent (37/41) of the Zycure group completed follow-up at six-month intervals for 1 year, of whom 78% (29/37) had no recurrence. There were no major treatment-related adverse effects, although 10 patients in Zycure group did not complete the treatment protocol for various reasons.
Conclusion We conclude that the solasodine glycoside cream Zycure is a safe therapy for basal cell carcinoma, with a cure rate of 66% at 8 weeks and 78% at 1 year follow-up.