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Solasodine glycoalkaloids: a novel topical therapy for basal cell carcinoma. A double‐blind, randomized, placebo‐controlled, parallel group, multicenter study
Author(s) -
Punjabi Sangeeta,
Cook L. J.,
Kersey P.,
Marks R.,
Cerio R.
Publication year - 2008
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/j.1365-4632.2007.03363.x
Subject(s) - medicine , adverse effect , randomized controlled trial , placebo , population , surgery , intention to treat analysis , clinical endpoint , incidence (geometry) , basal cell carcinoma , gastroenterology , basal cell , pathology , physics , optics , alternative medicine , environmental health
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). 1 DemographicsCharacteristicTreatment groupZycure n = 62Vehicle n = 32Age (in years): mean 68.9 70.0 Sex: male 33 17 Sex: female 29 15 Race: Caucasian 62 32Intervention 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.