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Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
NCT00007631 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Placebo
- DRUG Tretinoin 0.1% cream or placebo
Study Locations (7)
Arizona
- Carl T. Hayden VA Medical Center — Phoenix
California
- VA Medical Center, Long Beach — Long Beach
Florida
- VA Medical Center, Miami — Miami
Illinois
- Edward Hines, Jr. VA Hospital — Hines
North Carolina
- VA Medical Center, Durham — Durham
Oklahoma
- VA Medical Center, Oklahoma City — Oklahoma City
Rhode Island
- VA Medical Center, Providence — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,131 participants |
| Start Date | 1998-03 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007631
The ClinicalTrials.gov registry entry for NCT00007631 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Carcinoma, Squamous Cell appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00007631 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00007631 about?
NCT00007631 is a clinical study titled "Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer". 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 ...
What is the current status of trial NCT00007631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,131 participants. The study started on 1998-03. Estimated completion is 2006-07.
What conditions does trial NCT00007631 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell, Skin Neoplasms, Carcinoma, Basal Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00007631?
The interventions under investigation include: Placebo (OTHER), Tretinoin 0.1% cream or placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00007631?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00007631 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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