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Treatment of Actinic Keratoses (AK) on the Face

NCT02411851 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-02-01

No results posted yet for this 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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

ingenol mebutate 0.015%

one cycle of ingenol mebutate 0.015% on two 25 cm2 treatment areas

OTHER

dermasil lotion

Dermasil lotion has 1% dimethicone as its active ingredient - part of the family of silicone oils, is a hypoallergenic, noncomedogenic, and nonacnegenic agent

Sponsors & Collaborators

Principal Investigators

  • Mark Lebwohl, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411851 on ClinicalTrials.gov