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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years from the time of randomization
Awards & highlights

B3C 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.Check my eligibility
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.See study design
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.

B3C Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran aged 18 or older.

B3C Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

B3C 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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,303,966 Total Patients Enrolled
Martin A. Weinstock, MDStudy ChairProvidence VA Medical Center, Providence, RI
2 Previous Clinical Trials
2,085 Total Patients Enrolled

Media Library

Imiquimod (Immune Response Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT05212246 — Phase 3
Basal Cell Carcinoma Research Study Groups: 5% Imiquimod Cream, Placebo Vehicle Control Cream
Basal Cell Carcinoma Clinical Trial 2023: Imiquimod Highlights & Side Effects. Trial Name: NCT05212246 — Phase 3
Imiquimod (Immune Response Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05212246 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with using 5% Imiquimod cream?

"There is existing data to support the efficacy of 5% Imiquimod cream, and as this is a Phase 3 trial, it has received a safety score of 3."

Answered by AI

What hypothesis is this research trying to test?

"The primary outcome of this study is to assess the Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years. Secondary outcomes include Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year by medication compliance status which is defined as Skin exams will occur at baseline & 6 months after randomization. Diagnosis of a new facial BCC will be via biopsy under local anesthesia in an outpatient setting (standard of care). Every facial biopsy will be processed per standard operating procedures, as determined by the blinded clinician for the purposes"

Answered by AI

Are volunteers being accepted for this research project at the moment?

"Unfortunately, this study is no longer recruiting patients. It was initially posted on April 1st, 2023 but the most recent update was from January 14th, 2022. There are 2,557 other clinical trials that are still open and actively enrolling participants."

Answered by AI

Who else is applying?

What site did they apply to?
Providence VA Medical Center, Providence, RI
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Way too much sun exposure as a child growing up in Florida.
PatientReceived no prior treatments
~1087 spots leftby Jan 2030