Basal Cell Carcinoma Chemoprevention Trial

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
VA Office of Research and Development
Study ID
NCT05212246
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 5% Imiquimod cream — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 3, 2026
Status verified
May 2026
Primary completion
Aug 3, 2032
Completion
Aug 3, 2032

Study Design

Enrollment
1,630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Kel G Morin
[email protected]
(347) 346-0380
Martin A. Weinstock, MD (STUDY_CHAIR)

Find similar trials in Providence, RI

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Providence VA Medical Center, Providence, RI· Providence, RI

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