Trial intelligence / Profile preview

B3C: Basal Cell Carcinoma Chemoprevention Trial

NCT05212246Phase 3

Key facts

Status: Recruiting
Start: Oct 2026
Primary completion: Oct 2032
Countries: 1
Sponsor: VA Office of Research & Development
Modality: Nucleic Acid-Directed Small Molecules, Irreversible Covalent Inhibitors, Metabolically Activated Prodrugs

Drugs: imiquimod
Conditions: basal cell carcinoma (BCC)

Overview

Phase 3, randomised, double-blind trial in basal cell carcinoma (BCC) comparing 5% Imiquimod Cream with Placebo Vehicle Control Cream (2 arms). Primary endpoints: Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year and Basal Cell Carcinoma (BCC) free time to a new BCC on the face at 3 years. Started Oct 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

5% Imiquimod Cream
Topical 5% Imiquimod cream applied once daily to the face for 12 weeks.
Placebo Vehicle Control Cream
Placebo vehicle control cream applied once daily to the face for 12 weeks.

Who it enrols

Veterans with 2 or more qualifying basal cell carcinoma lesions in the prior 5 years, excluding those with recent field therapy, prior facial radiation, or certain systemic therapies.

Endpoints

Primary

Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face1 year
Basal Cell Carcinoma (BCC) free time to a new BCC on the face3 years

Secondary

Proportion of participants with a new Squamous Cell Carcinoma (SCC) on the face1 year
Squamous Cell Carcinoma (SCC) free time to a new SCC on the face3 years
Total Actinic Keratosis (AK) reduction on the face over time3 years
Actinic Keratosis (AK) reduction in each Olsen grade on the face over time3 years
Proportion of participants with any facial Actinic Keratosis (AK) biopsies or surgical removal on the face1 year
Proportion of participants with a cheek or forehead primary Basal Cell Carcinoma (BCC) versus other areas of the face1 year
Proportion of participants with a facial primary Basal Cell Carcinoma (BCC) of aggressive histologic subtypes1 year
Proportion of participants who have experienced a facial primary Basal Cell Carcinoma (BCC) of high severity1 year

Beyond the preview

Go deeper on NCT05212246.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05212246.