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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00007631

Public ClinicalTrials.gov record NCT00007631. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 12:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

CSP #402 - VA Topical Tretinoin Chemoprevention Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00007631
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,131 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 1998
Primary completion
Oct 31, 2004
Completion
Jun 30, 2006
Last update posted
Jan 29, 2009

1998 – 2006

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Carl T. Hayden VA Medical Center Phoenix Arizona 85012
VA Medical Center, Long Beach Long Beach California 90822
VA Medical Center, Miami Miami Florida 33125
Edward Hines, Jr. VA Hospital Hines Illinois 60141-5000
VA Medical Center, Durham Durham North Carolina 27705
VA Medical Center, Oklahoma City Oklahoma City Oklahoma 73104
VA Medical Center, Providence Providence Rhode Island 02908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00007631, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 29, 2009 · Synced Sep 11, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00007631 live on ClinicalTrials.gov.

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