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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
5% Imiquimod cream
DrugTopical 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
DrugThe 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.
Treatment groups
1,630 Participants
are divided into 2 treatment groupsGroup A: 5% Imiquimod CreamExperimental treatment 1 intervention
Group B: Placebo Vehicle Control CreamPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year from the time of randomization2
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.
Time frame
3 years from the time of randomizationSecondary outcomes
1
Proportion of participants with a new Squamous Cell Carcinoma (SCC) on the face at 1 year
Diagnosis of a new SCC 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, and the biopsy will also 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 SCC. 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.
Time frame
1 year from the time of randomization2
Squamous Cell Carcinoma (SCC) free time to a new SCC on the face over 3 years
Squamous Cell Carcinoma (SCC) free time to a new SCC on the face over 3 years is defined as the time in years from treatment randomization to the first occurrence of a new SCC on the face. Participants who do not develop a new SCC on the face by 3 years will be considered censored observations.
Time frame
3 years from the time of randomization3
Total Actinic Keratosis (AK) reduction on the face over time during treatment and active follow-up
AK reduction persistence over time will be assessed using total AK counts (on the face only) evaluated at in-person visits at weeks 6 and 12 and months 6, 12, 18, 24, 30, and 36, and will be analyzed as a repeated measures outcome.
Time frame
3 years from the time of randomization4
Actinic Keratosis (AK) reduction in each Olsen grade on the face over time during treatment and active follow-up
AK reduction in each Olsen grade on the face over time will be assessed using AK counts (on the face only) in each Olsen grade evaluated at in-person visits at weeks 6 and 12 and months 6, 12, 18, 24, 30, and 36, and will be analyzed as a repeated measures outcome.
Time frame
3 year from the time of randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: