Basal Cell Carcinoma Chemoprevention Trial
B3C
CSP #2019 - Basal Cell Carcinoma Chemoprevention Trial (B3C)
1 other identifier
interventional
1,630
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 3, 2032
January 22, 2026
January 1, 2026
6 years
January 14, 2022
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year
Skin exams will occur at baseline and at 6-month intervals after study randomization. Diagnosis of a new BCC will be ascertained by a biopsy under local anesthesia in an outpatient setting, as is the standard of care. Every biopsy performed on the face of a participant during the trial will be processed per standard clinical operating procedures, as determined by their blinded clinician for the purposes of patient management. The biopsy will be sent for reading by a blinded central dermatopathologist with known high reliability (intra-rater and inter-rater with two other board-certified dermatopathologists) for diagnosing BCC. This central dermatopathologist diagnosis will be used for study purposes. Skin cancers diagnosed outside of the VA, and associated surgeries, will be systematically sought in all participants by participant interview and review of medical records to ensure that the outcome measure is complete.
1 year from the time of randomization
Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years
Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years is defined as the time in years from treatment randomization to the first occurrence of a new BCC on the face. Participants who do not develop a new BCC on the face by 3 years will be considered censored observations. Skin exams will occur at baseline and at 6-month intervals after study randomization.
3 years from the time of randomization
Secondary Outcomes (26)
Proportion of participants with a new Squamous Cell Carcinoma (SCC) on the face at 1 year
1 year from the time of randomization
Squamous Cell Carcinoma (SCC) free time to a new SCC on the face over 3 years
3 years from the time of randomization
Total Actinic Keratosis (AK) reduction on the face over time during treatment and active follow-up
3 years from the time of randomization
AK reduction in each Olsen grade on the face over time during treatment and active follow-up
3 year from the time of randomization
Proportion of participants with any facial Actinic Keratosis (AK) biopsies or surgical removal on the face at 1 year
1 year from the time of randomization
- +21 more secondary outcomes
Study Arms (2)
5% Imiquimod Cream
EXPERIMENTALTopical 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
PLACEBO COMPARATORThe 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
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.
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
You may qualify if:
- Veteran age 18 years or older
You may not qualify if:
- 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.
- AK or KC field therapy on the face (5-FU cream, 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.
- 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 SCC than 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin A. Weinstock, MD
Providence VA Medical Center, Providence, RI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 28, 2022
Study Start
May 1, 2026
Primary Completion (Estimated)
May 3, 2032
Study Completion (Estimated)
May 3, 2032
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 10 years after primary publication
After the main results of this study have been published, de-identified data from the study may be shared with other VA investigators, other Federal health agencies, or academic institutions for additional analyses provided this use has been approved by CSP, the appropriate VA oversight committee(s), and there is an agreement in place that defines the limits of this use. With the participant's approval and as approved by local Institutional Review Boards (IRBs), deidentified study data will be moved into a data repository where other CSP studies are maintained after the study has ended. This data could be used for future research on the conditions, characteristics, complications, and treatments covered in the proposed work.