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NCT00007631 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Carcinoma, Squamous Cell and Skin Neoplasms, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 3
Development phase
1,131
Enrollment target
7
Study locations

NCT00007631: Completed Phase 3 study of Carcinoma, Squamous Cell and Skin Neoplasms, sponsored by US Department of Veterans Affairs.

NCT00007631 is a Phase 3 study of Carcinoma, Squamous Cell and Skin Neoplasms that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 1,131 participants, above the 180-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (528% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00007631, a Phase 3 study of Carcinoma, Squamous Cell and Skin Neoplasms, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 3
Development phase
1,131 participants
Enrollment target
7
Study locations

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.

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

FieldValue
Enrollment Target 1,131 participants
Start Date 1998-03
Est. Completion 2006-07
Phase Phase 3
US Department of Veterans Affairs

632 total trials

What the finished NCT00007631 record still lists

NCT00007631 is an interventional study that assigns participants to a tested intervention. Its 1,131 participants enrollment target places it among the larger protocols in the corpus, above the 180-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (528% higher).

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.

NCT00007631 lists 7 locations in 7 states (Arizona, California, Florida).

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.

What interventions are being tested in trial NCT00007631?

The interventions under investigation include: Placebo (OTHER), Tretinoin 0.1% cream or placebo (DRUG).

Who is sponsoring clinical trial NCT00007631?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Carcinoma, Squamous Cell

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00007631's enrollment target sits among peer trials

1,131 1st of 14 higher than 14 of 14 other Carcinoma, Squamous Cell trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Squamous Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00007631, the US trial registry maintained by the National Library of Medicine. NCT00007631 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.