Imiquimod Cream for Basal Cell Carcinoma
(B3C Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: VA Office of Research and Development

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Veterans aged 18+ who've had at least two basal cell carcinomas in the past five years, with one on their face, neck, ears, or scalp. Excluded are those with recent facial treatments that might interfere with the study cream, certain cancer therapies within two months, high-risk genetic disorders for skin cancer, organ transplant recipients, known allergies to trial creams, pregnant or breastfeeding women and those not using birth control.

Inclusion Criteria

I am a veteran aged 18 or older.

I have had 2 or more BCC lesions in the last 5 years, with at least one on my face, neck, ears, or scalp.

Exclusion Criteria

I have a history of skin lymphoma.

I have a genetic condition that greatly increases my cancer risk.

I am a woman who can have children and do not want to use birth control.

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Participant Groups

The trial is testing if Imiquimod (IMQ) cream can prevent new basal cell carcinomas compared to a placebo. Participants will apply either IMQ or placebo cream nightly for 12 weeks. The effectiveness will be evaluated after one year and again over three years.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 5% Imiquimod CreamExperimental Treatment1 Intervention

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.

Group II: Placebo Vehicle Control CreamPlacebo Group1 Intervention

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.