Recruiting
Phase 3

Imiquimod

Sponsor:

VA Office of Research and Development

Code:

NCT05212246

Conditions

Basal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

5% Imiquimod cream

Placebo Vehicle Control Cream

Study Details

Brief summary:

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.

Conditions

Basal Cell Carcinoma

Study ID

NCT05212246

Start date

Oct 6, 2026

Status verified date

Oct, 2026

Completion date

Oct 6, 2032

Anticipated

Primary completion date

Oct 6, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 5% Imiquimod Cream

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 comparator: Placebo Vehicle Control Cream

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.

Interventions

5% Imiquimod cream

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

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.

Primary outcome measure

  • Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year [ Time Frame: 1 year from the time of randomization ]
  • Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years [ Time Frame: 3 years from the time of randomization ]

Central Contacts and Locations

Central contacts

Brynn Chouinard, BA

(401) 273-7100Brynn.chouinard@va.gov

Abrar Qureshi, MD

(401) 273-7100Abrar.qureshi@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Christine Gonzaga, RN

858-642-3698Christine.gonzaga@va.gov

Laura Romero, MD

8585528585Laura.romero@va.gov

Bay Pines VA Healthcare System, Pay Pines, FL

Recruiting

Bay Pines, Florida, United States, 33744-0000

Contacts

Mini Sajan, PhD

727-621-3624Mini.sajan@va.gov

Daniel Hogan, MD

7273986661Daniel.hogan@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Sydney Conley, BS

612-467-6768sydney.conley@va.gov

Noah Goldfarb, MD

6124612737noah.goldfarb@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Breantie C Parotti

919-286-0411Breantie.parotti@va.gov

Haley Blaisure

9193582501Haley.blaisure@va.gov

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Cassidy Chester

385-414-8824Cassidy.chester@va.gov

Jamie Rhoads, MD

8505917888Jamie.rhoads@va.gov

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Recruiting

Milwaukee, Wisconsin, United States, 53295-0001

Contacts

Sage Coles-Dogan, BA

414-384-2000Sage.Coles-Dogan@va.gov

Olushola Akinshemoyin-Vaughn, MD

3013847095Olushola.AkinshemoyinVaughn@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Basal Cell Carcinoma
  • chemoprevention
  • imiquimod
  • facial skin cancer
  • skin cancer prevention
  • squamous cell carcinoma
  • keratinocyte carcinoma
  • actinic keratosis
  • quality of life
  • side effects
  • treatment compliance
  • automated text messaging
  • cost comparison and cost effectiveness
  • implementation science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.