RECRUITING Phase 3 ClinicalTrials.gov

Basal Cell Carcinoma Chemoprevention Trial

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT05212246

Registry updated: 2026-10-19

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Description

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.

Interventions

5% Imiquimod cream (Drug)
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.
Placebo Vehicle Control Cream (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Veteran * 2 (or more) qualifying basal cell carcinoma (BCC) lesions in the prior 5 years, with at least one located on the face, neck, ears, or scalp. "Qualifying lesions are those that meet the two inclusion criterion bullet points below, and none of the exclusion criteria listed in "B." * 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 Criteria: * 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

Conditions

Basal Cell Carcinoma

Locations

VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States
Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States
VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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