Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by LEO Pharma. The registered enrollment target is 563 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03115476
The ClinicalTrials.gov registry entry for NCT03115476 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 563 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vehicle gel is the first listed.
NCT03115476 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.