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NCT05212246 · ClinicalTrials.gov registry record · Phase 3

Basal Cell Carcinoma Chemoprevention Trial

A Phase 3 study, sponsored by VA Office of Research and Development.

Not yet
Registry status
Phase 3
Development phase
1,630
Enrollment target

NCT05212246: Clinical Trial Phase 3 study, sponsored by VA Office of Research and Development.

NCT05212246 is a Phase 3 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 1,630 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05212246, a Phase 3 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.

NOT YET RECRUITING
Registry status
Phase 3
Development phase
1,630 participants
Enrollment target

Study 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.

Primary Outcome

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 dermatopathol

Interventions

  • DRUG 5% Imiquimod cream
  • DRUG Placebo Vehicle Control Cream

Trial Details

FieldValue
Enrollment Target 1,630 participants
Start Date 2026-08-03
Est. Completion 2032-08-03
Phase Phase 3
VA Office of Research and Development

1,668 total trials

What is known before NCT05212246 opens enrollment

NCT05212246 is an interventional study that assigns participants to a tested intervention. Its 1,630 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (111% higher).

The record links to 0 conditions, and to 2 interventions - of which 5% Imiquimod cream is the first listed.

NCT05212246 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05212246 about?

NCT05212246 is a clinical study titled "Basal Cell Carcinoma Chemoprevention 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 app...

What is the current status of trial NCT05212246?

This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 1,630 participants. The study started on 2026-08-03. Estimated completion is 2032-08-03.

What interventions are being tested in trial NCT05212246?

The interventions under investigation include: 5% Imiquimod cream (DRUG), Placebo Vehicle Control Cream (DRUG).

Who is sponsoring clinical trial NCT05212246?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05212246's enrollment target sits among peer trials

1,630 141st of 2000 higher than 1,860 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05212246, the US trial registry maintained by the National Library of Medicine. NCT05212246 (large enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.