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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Imiquimod cream can prevent basal cell carcinoma (BCC), a common skin cancer, on the face. Participants will apply either Imiquimod cream or a placebo cream daily before bed for 12 weeks. The study targets Veterans who have had two or more BCC spots in the past five years, with at least one on the face, neck, ears, or scalp. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Imiquimod cream is likely to be safe for humans?

Research has shown that Imiquimod cream is usually well-tolerated for treating certain skin cancers, such as superficial basal cell carcinoma. Most patients can use the cream without major issues, though some may experience skin irritation or redness at the application site, which is common with skin treatments.

Importantly, there is no major concern about the cream causing issues in other parts of the body, so it is considered safe for most people to use on their skin. The cream aids the immune system in fighting skin cancer cells.

For those considering joining a trial, it is reassuring to know that breaks can be taken if side effects become bothersome. This allows for a pause in using the cream to let the skin recover if needed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for basal cell carcinoma?

Unlike the standard treatments for basal cell carcinoma, which often involve surgical procedures or topical chemotherapy agents like 5-fluorouracil, Imiquimod cream offers a non-invasive alternative that can be applied directly to the skin. Imiquimod is unique because it works by stimulating the immune system to attack cancerous cells, rather than physically removing or chemically destroying them. This novel mechanism of action makes it particularly appealing as it could potentially lead to fewer side effects and a more targeted approach to eliminating cancer cells. Researchers are excited about Imiquimod because it can be easily applied at home, offering convenience and possibly improving patient adherence to treatment.

What evidence suggests that Imiquimod might be an effective treatment for basal cell carcinoma?

Research has shown that Imiquimod cream effectively treats basal cell carcinoma (BCC), a common type of skin cancer. In this trial, participants will receive either the 5% Imiquimod cream or a placebo vehicle control cream. Studies have found that daily use of 5% Imiquimod cream is well tolerated and successfully treats nodular BCCs. One study found it more effective than other treatments, such as special light therapy (MAL-PDT) and the anti-cancer drug 5-fluorouracil, for certain BCC types over five years. Patients who used Imiquimod daily for 6 to 12 weeks showed positive results in clearing BCC. This cream boosts the immune system to fight cancer cells, making it a promising option for treating BCC on the face. ^{6 7 8 9 10}

Who Is on the Research Team?

Martin A. Weinstock, MD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4924409/

Facial Basal Cell Carcinoma Treated with Topical 5 ... We present two cases of nodular pigmented BCCs on the face in elderly women successfully treated with 5% imiquimod cream application resulting in complete ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/410920

Fifty-five Basal Cell Carcinomas Treated With Topical ... In conclusion, our data suggest that imiquimod treatment is effective in most cases of noninfiltrative BCCs, but more trials are required to determine the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X17330452

Five-Year Results of a Randomized Controlled Trial ... The results of our study showed that treatment with 5% imiquimod cream is superior to both MAL-PDT and 5-fluorouracil in treatment of sBCC, 5 years after ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12224977/

Efficacy of topical 5% imiquimod cream for the treatment ... Topical 5% imiquimod cream is well tolerated and most effective in treating nodular BCC when applied once daily for 7 days per week for either 12 or 6 weeks.

5. jaadinternational.org jaadinternational.org/article/S2666-3287(23)00146-3/fulltext

Superficial basal cell carcinoma treated with curettage ... It has been reported that curettage followed by daily topical application of imiquimod 5% cream for 6 weeks for a group of patients with either ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf

ALDARA [al dar' a] (imiquimod) Cream, 5% For Dermatologic ... The safety and efficacy of treating superficial basal cell carcinoma (sBCC) lesions on the face, head and anogenital area have not been established. The ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557413/

Imiquimod - StatPearls - NCBI Bookshelf - NIH [5] Topical imiquimod can treat superficial basal cell carcinoma on low-risk sites, thus excluding the high-risk H-zone of the face, which ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/imiquimod-topical-route/description/drg-20067474

Imiquimod (topical route) - Side effects & dosage Imiquimod may be used to treat certain types of skin cancer called superficial basal cell carcinoma (sBCC). Imiquimod works on the immune ...

9. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/478986

Efficacy of Topical 5% Imiquimod Cream for the Treatment ... Conclusions Topical 5% imiquimod cream is well tolerated and most effective in treating nodular BCC when applied once daily for 7 days per week for either 12 or ...

10. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/i/imiquimodcrm.pdf

Imiquimod Cream 5% w/w topical cream. use of Imiquimod Cream in patients with actinic keratosis or superficial basal cell carcinoma should not pose any systemic safety concern.