Imiquimod cream to help prevent facial basal cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, parallel-group study comparing 5% imiquimod cream with a placebo vehicle to prevent facial basal cell carcinoma in high-risk veterans. Participants apply the assigned cream nightly before bed for 12 weeks, and are followed for one year and then up to three years to assess the occurrence of new facial BCC lesions. The study plans to enroll about 1,630 veterans across 17 VA medical centers. The primary objective is to determine if topical imiquimod reduces the rate of new facial BCC compared with placebo. Eligible participants have two or more qualifying BCC lesions in the past five years, with at least one on the face, neck, ears, or scalp, and have not recently received related therapies on the treated area.

Why it matters

Who can join: the full rules

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 imiquimod (IMQ) treatment. After 2 months, these patients can be included
* imiquimod (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 imiquimod (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 imiquimod (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

Where it's running

• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• VA San Diego Healthcare System, San Diego, CA
  San Diego, California, United States Recruiting
• Bay Pines VA Healthcare System, Pay Pines, FL
  Bay Pines, Florida, United States Recruiting
• Minneapolis VA Health Care System, Minneapolis, MN
  Minneapolis, Minnesota, United States Recruiting
• Durham VA Medical Center, Durham, NC
  Durham, North Carolina, United States Recruiting
• VA Salt Lake City Health Care System, Salt Lake City, UT
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Brynn Chouinard, BA
• Email: Brynn.chouinard@va.gov
• Phone: (401) 273-7100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.