Isotretinoin-basal cell carcinoma prevention trial. Design, recruitment results, and baseline characteristics of the trial participants

Joseph Tangrea*, Brenda Edwards, Anne Hartman, Philip Taylor, Gary Peck, Stuart Salasche, Padman Menon, George Winton, Ramsey Mellette, Marshall Guill, June Robinson, Jere Guin, Howard Stoll

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

The Isotretinoin-Basal Cell Carcinoma Prevention Trial (ISO-BCC Study) is a double-masked, randomized, placebo controlled, multicenter clinical trial. It is the first intramural cancer chemoprevention trial sponsored by the Division of Cancer Prevention and Control of the National Cancer Institute. This trial was designed to evaluate the effectiveness of chronic administration of low dosage levels (10 mg) of a synthetic retinoid, isotretinoin, in reducing the incidence of basal cell carcinoma in a high-risk population and to determine the incidence and severity of side effects associated with this long-term treatment. Between 1984 and 1987, eight clinical centers enrolled 981 participants between the ages of 40 and 75, who had two or more biopsy proven basal cell carcinomas in the 5 years before trial entry. This article describes the trial design, recruitment results, and baseline characteristics of the participant population in the ISO-BCC Study.

Original languageEnglish (US)
Pages (from-to)433-450
Number of pages18
JournalControlled Clinical Trials
Volume11
Issue number6
DOIs
StatePublished - Dec 1990

Keywords

  • basal cell carcinoma
  • chemoprevention
  • design
  • isotretinoin

ASJC Scopus subject areas

  • Pharmacology

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