Basal Cell Carcinoma Chemoprevention Trial

This study is testing if a cream called 5% Imiquimod can help prevent new basal cell carcinomas (BCCs) on the face. BCC is a common type of skin cancer. You might be able to join if you are a veteran aged 18 or older and have had at least two BCCs in the past five years, with one on your face, neck, ears, or scalp. Participants will apply either 5% Imiquimod cream or a placebo cream (which looks the same but has no medicine) to their face once a day for 12 weeks. Researchers will then track how many participants develop new BCCs on their face over one year and over three years. This study aims to see if 5% Imiquimod can reduce the number of new BCCs.

Study design: This is a randomized, double-blind study comparing 5% Imiquimod cream to a placebo cream. It plans to enroll 1630 veterans at high risk for BCC.
What's involved: You would apply the assigned cream to your face once daily for 12 weeks. The cream should be left on for 6-10 hours each night.
Compensation: Not stated in the trial record.
Follow-up: Researchers will track the development of new BCCs for one year and then for three years after you finish applying the cream.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Basal Cell Carcinoma Chemoprevention Trial

Not Yet Recruiting

PHASE3Ages 18+InterventionalPrevention

VA Office of Research and Development

~1,630 participants

Updated 2026-08-21 on ClinicalTrials.gov

What's tested:5% Imiquimod creamPlacebo Vehicle Control Cream

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over 1 year from the time of randomization

+1 more outcome measured

Conditions

Basal Cell Carcinoma

Where it's being run

1 sites across 1 states

Rhode Island1

Study leadership

Martin A. Weinstock, MD · STUDY_CHAIR · Providence VA Medical Center, Providence, RI

Who to contact

Kel G Morin

[email protected]

(347) 346-0380

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Veteran

Qualifying lesions not in a field of prior radiation therapy

Qualifying lesions not a recurrence after treatment, but the original lesion can qualify whether it recurred or not

Exclusion

Actinic Keratosis (AK) or Keratinocyte Carcinoma (KC) field therapy on the face (5-FU cream, imiquimod (IMQ), diclofenac gel, chemical peel, or photodynamic therapy) for BCC treatment on the face in the last 2 months because it can cause inflammation that may interfere with the IMQ treatment. After 2 months, these patients can be included.

IMQ therapy on the face in the past year, although such therapy in the more distant past is not an exclusion

Suspicious skin lesions suggestive of any type of skin cancer present on the face at the initial exam conducted for the study must be removed and have another skin exam to confirm the facial skin cancer is cleared for 1 month prior to randomization so that the investigators can be confident that skin cancer lesions that arise during the trial are new

Currently receiving or received in the past two months: immune checkpoint inhibitor, hedgehog pathway inhibitor, or oral capecitabine

History of cutaneous T-cell lymphoma within the past year, but low-grade prostate cancer, patch stage CTCL, breast cancer, and history of solid hematologic cancer deemed to be in remission will be included

Genetic disorder associated with very high basal cell skin cancer risk (i.e., basal cell nevus syndrome, xeroderma pigmentosum) because prevention efforts with IMQ may have dramatically different efficacy in these patients compared to the general high-risk population

Solid organ or bone marrow transplant recipient such as renal, hepatic, or cardiac transplant because these patients are at increased risk of KC (much greater risk of squamous cell carcinoma (SCC) than basal cell carcinoma (BCC)) and the associated immunodeficiency may affect the effectiveness of IMQ

Radiation therapy to the face

Known allergy to IMQ or cream vehicle

Woman currently pregnant or breast feeding

Woman of childbearing potential unwilling to use birth control

Judged by investigator to have a very high mortality risk within a year due to co-morbid illness

Judged by investigator to be unlikely to comply with protocol requirements

Judged by investigator not to be competent to provide informed consent

Unable to communicate in English

Enrolled in another therapeutic interventional trial

What this trial measures

Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year1 year from the time of randomization
Skin exams will occur at baseline and at 6-month intervals after study randomization. Diagnosis of a new BCC will be ascertained by a biopsy under local anesthesia in an outpatient setting, as is the standard of care. Every biopsy performed on the face of a participant during the trial will be processed per standard clinical operating procedures, as determined by their blinded clinician for the purposes of patient management. The biopsy will be sent for reading by a blinded central dermatopathologist with known high reliability (intra-rater and inter-rater with two other board-certified dermatopathologists) for diagnosing BCC. This central dermatopathologist diagnosis will be used for study purposes. Skin cancers diagnosed outside of the VA, and associated surgeries, will be systematically sought in all participants by participant interview and review of medical records to ensure that the outcome measure is complete.
Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years3 years from the time of randomization
Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years is defined as the time in years from treatment randomization to the first occurrence of a new BCC on the face. Participants who do not develop a new BCC on the face by 3 years will be considered censored observations. Skin exams will occur at baseline and at 6-month intervals after study randomization.

Trialytics