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Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer

NCT00007631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1131

Last updated 2009-01-30

No results posted yet for this study

Summary

One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell and/or basal cell carcinoma were enrolled at six participating centers over a four-year period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.

Conditions

  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Skin Neoplasms

Interventions

DRUG

Tretinoin 0.1% cream or placebo

OTHER

Placebo

Patients receive placebo for same amount of time

Sponsors & Collaborators

Principal Investigators

  • Martin A. Weinstock, MD · VA Medical Center, Providence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2004-11-30
Completion
2006-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007631 on ClinicalTrials.gov