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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 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02411851
The ClinicalTrials.gov registry entry for NCT02411851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ingenol mebutate 0.015% is the first listed.
NCT02411851 reports 0 study locations.
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.
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