Solasodine glycoalkaloids: a novel topical therapy for basal cell carcinoma. A double-blind, randomized, placebo-controlled, parallel group, multicenter study

Int J Dermatol. 2008 Jan;47(1):78-82. doi: 10.1111/j.1365-4632.2007.03363.x.


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).

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Carcinoma, Basal Cell / drug therapy*
  • Double-Blind Method
  • Female
  • Glycosides / administration & dosage*
  • Glycosides / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Occlusive Dressings
  • Patient Dropouts
  • Pharmaceutical Vehicles / adverse effects
  • Pharmaceutical Vehicles / chemistry
  • Skin Neoplasms / drug therapy*
  • Solanaceous Alkaloids / administration & dosage*
  • Solanaceous Alkaloids / adverse effects
  • Treatment Failure
  • Treatment Outcome


  • Antineoplastic Agents
  • Glycosides
  • Pharmaceutical Vehicles
  • Solanaceous Alkaloids
  • solasodine