Imiquimod Cream for Basal Cell Carcinoma

(B3C Trial)

Overseen By Kel G Morin

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must not be taking: Immune inhibitors, Hedgehog inhibitors

Disqualifiers: Pregnancy, Transplant recipient, Genetic disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

1630 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving or have received certain treatments like immune checkpoint inhibitors, hedgehog pathway inhibitors, or oral capecitabine in the past two months.

What data supports the effectiveness of the drug Imiquimod cream for treating basal cell carcinoma?

Research shows that Imiquimod 5% cream is effective in treating different types of basal cell carcinoma (BCC), including superficial and nodular forms. Studies have reported successful treatment outcomes, with high clearance rates and sustained results over several years, making it a viable non-surgical option for BCC. ^{1 2 3 4 5}

Is Imiquimod cream safe for treating basal cell carcinoma?

Imiquimod cream is generally considered safe for treating basal cell carcinoma and has been approved by the US Food and Drug Administration for this use, as well as for actinic keratosis and genital-perianal warts. ^{1 3 6 7 8}

How does the drug Imiquimod cream differ from other treatments for basal cell carcinoma?

Imiquimod cream is unique because it is a topical treatment that modifies the immune response to help clear basal cell carcinoma, unlike traditional surgical methods. It is applied directly to the skin, making it a non-invasive option, and has shown high clearance rates for superficial and nodular types of basal cell carcinoma. ^{1 9 10 11 12}

Research Team

Martin A. Weinstock, MD

Principal Investigator

Providence VA Medical Center, Providence, RI

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply Imiquimod or placebo cream to the face daily at bedtime for 12 weeks

12 weeks

In-person visits at weeks 6 and 12

Active Follow-up

Participants are monitored for study outcomes with in-person visits and telephone interviews

3 years

In-person visits at months 6, 12, 18, 24, 30, and 36; telephone interviews at months 9, 15, 21, 27, and 33

Passive Follow-up

Study outcome information captured from medical records

1 year

Treatment Details

Interventions

• Imiquimod
• Placebo Vehicle Control Cream

Trial Overview 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.

Participant Groups

Group I: 5% Imiquimod Cream Experimental Treatment 1 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 Cream Placebo Group 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of multifocal pigmented basal cell carcinomas with the application of topical 5% imiquimod cream. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Has imiquimod 5% cream a role in the management of recurrent basal cell carcinoma? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy with imiquimod 5% cream for eyelid nodular basal cell carcinoma. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Melanoma in Situ Treated with Topical Imiquimod for Management of Persistently Positive Margins: A Review of Treatment Methods. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Imiquimod: in superficial basal cell carcinoma. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Open study of the efficacy and mechanism of action of topical imiquimod in basal cell carcinoma. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Pigmented basal cell carcinoma successfully treated with 5% Imiquimod cream. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Superficial basal cell carcinoma on face treated with 5% imiquimod cream. [2019]