Basal Cell Carcinoma Chemoprevention Trial
ConditionBasal Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- 5% Imiquimod cream
- Placebo Vehicle Control Cream
Treatment groups
1,630 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov