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NCT03115476 · ClinicalTrials.gov registry record · Phase 3
A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
A Phase 3 study, sponsored by LEO Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 563
- Enrollment target
NCT03115476: Clinical Trial Phase 3 study, sponsored by LEO Pharma.
NCT03115476 is a Phase 3 study that was terminated before completion, run by LEO Pharma. The registered enrollment target is 563 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03115476, a Phase 3 study, was terminated before completion, sponsored by LEO Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 563 participants
- Enrollment target
Study Summary
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
Primary Outcome
Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis
Interventions
- OTHER Vehicle gel
- DRUG ingenol disoxate gel 0.018%
- DRUG ingenol disoxate gel 0.037%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 3 |
Why NCT03115476 stopped before completion
NCT03115476 is an interventional study that assigns participants to a tested intervention. The registered 563 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle gel is the first listed.
NCT03115476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03115476 about?
NCT03115476 is a clinical study titled "A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp". One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic...
What is the current status of trial NCT03115476?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 563 participants. The study started on 2017-06-16. Estimated completion is 2018-03-12.
What interventions are being tested in trial NCT03115476?
The interventions under investigation include: Vehicle gel (OTHER), ingenol disoxate gel 0.018% (DRUG), ingenol disoxate gel 0.037% (DRUG).
Who is sponsoring clinical trial NCT03115476?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03115476's enrollment target sits among peer trials
563 668th of 2000 higher than 1,332 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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