Basal Cell Carcinoma Chemoprevention Trial (NCT05212246)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (17 items).
Location: Providence VA Medical Center, Providence, RI — Providence, Rhode Island
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Providence VA Medical Center, Providence, RI — Providence, Rhode Island
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.