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Immune Response Modifier

Imiquimod Cream for Basal Cell Carcinoma (B3C Trial)

Phase 3

Waitlist Available

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veteran age 18 years or older

Be older than 18 years old

Must not have

History of cutaneous T-cell lymphoma

Genetic disorder associated with very high cancer risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years from the time of randomization

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial will compare Imiquimod vs. placebo cream for preventing basal cell carcinoma of the skin on the face. 1630 Veterans at high risk of BCC will be recruited from 17 VA medical centers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Imiquimod may cause local skin reactions like redness, swelling and itching where it's applied. It could also lead to flu-like symptoms such as fever and fatigue. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of skin lymphoma.

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

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

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I am considered unable to understand and give consent for treatment.

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I have received radiation therapy to my face.

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I have suspicious skin marks on my face that might be cancer.

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I have used IMQ therapy on my face within the last year.

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I cannot communicate in English.

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I have received a solid organ or bone marrow transplant.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years

Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year

Secondary study objectives

Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years by medication compliance status

Counts of Actinic Keratosis (AK) on the face over time during treatment and active follow-up

Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well-being score at 1 year

+38 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 11Eligibility criteria met