Veterans test daily cream to stop face skin cancers
NCT ID NCT05212246
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether a daily imiquimod cream applied to the face for 12 weeks can prevent new basal cell carcinomas (BCC) in 1,630 veterans at high risk. Participants apply either the active cream or a placebo and are followed for up to 3 years with skin exams. The goal is to see if the cream reduces new BCCs on the face compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Imiquimod cream (5%)
- What this could lead to
- If it works, this could offer a way to prevent new basal cell skin cancers on the face in people at high risk.
- What could go wrong
- This is a large Phase 3 trial, but it only includes veterans and focuses on the face. Side effects like skin irritation may limit use, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,630 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734, United States
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Other studies related to the condition(s) this trial covers.
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