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NCT02411851 · ClinicalTrials.gov registry record · Phase 1
Treatment of Actinic Keratoses (AK) on the Face
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02411851: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02411851 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411851, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. Ingenol mebutate gel 0.015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, these localized skin responses (eg erythema, erosion/ulceration, edema, etc.) can often be unpleasant and unsightly. Currently, there are no clinical studies evaluating combination therapies (eg topical steroids, emollients) with ingenol mebutate 0.015% that would decrease irritation and improve wound healing while maintaining efficacy.
Primary Outcome
Investigator assessment of the degree of irritation as measured by local skin reactions at day 57 as compared to baseline.
Interventions
- DRUG ingenol mebutate 0.015%
- OTHER dermasil lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02411851 record still lists
NCT02411851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which ingenol mebutate 0.015% is the first listed.
NCT02411851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02411851 about?
NCT02411851 is a clinical study titled "Treatment of Actinic Keratoses (AK) on the Face". Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active compound in the sap from Euphorbia p...
What is the current status of trial NCT02411851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02411851?
The interventions under investigation include: ingenol mebutate 0.015% (DRUG), dermasil lotion (OTHER).
Who is sponsoring clinical trial NCT02411851?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02411851's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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