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NOT YET RECRUITING
NCT05212246
PHASE3

Basal Cell Carcinoma Chemoprevention Trial

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carcinoma (BCC) of the skin on the face at one year and over 3 years after therapy. Participants will apply the IMQ or placebo cream to the face daily at bedtime for 12 weeks. This study will recruit 1630 Veterans at high risk of BCC from 17 VA medical centers.

Official title: CSP #2019 - Basal Cell Carcinoma Chemoprevention Trial (B3C)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1630

Start Date

2026-05-01

Completion Date

2032-05-03

Last Updated

2026-01-22

Healthy Volunteers

Yes

Interventions

DRUG

5% Imiquimod cream

Topical 5% Imiquimod cream will be applied once daily to the face in a thin layer for 12 weeks. Three packets of cream will be defined as one dose or application. The cream should be applied to the face prior to normal sleeping hours (it is readily absorbed) and left on the skin for 6-10 hours (i.e. overnight). Rest periods will be allowed if bothersome side effects occur.

DRUG

Placebo Vehicle Control Cream

The placebo vehicle control cream will be a virtually identical cream (to the Imiquimod cream) that contains no Imiquimod. This cream will be applied once daily to the face in a thin layer for 12 weeks. Three packets of cream will be defined as one dose or application. The cream should be applied to the face prior to normal sleeping hours (it is readily absorbed) and left on the skin for 6-10 hours (i.e. overnight). Rest periods will be allowed if bothersome side effects occur.

Locations (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States