Treatment of Actinic Keratoses (AK) on the Face

NCT02411851 | Completed Phase 1 DMC

• 1 other identifier: GCO 14-1319
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Local Skin Reaction (LSR)

  Investigator assessment of the degree of irritation as measured by local skin reactions at day 57 as compared to baseline.

  up to day 57

Secondary Outcomes (2)

• AK lesion count

  baseline and day 57

• Visual Analog Scale (VAS) Survey

  baseline and day 57

Study Arms (2)

Ingenol mebutate alone

ACTIVE COMPARATOR

At Visit 1, ingenol mebutate 0.015% alone on the second 25 cm2 treatment area. The treatment area receiving ingenol mebutate 0.015% alone will apply the medication as directed per approved drug labeling. Patients will apply ingenol mebutate gel on Day 2 and Day 3.

Drug: ingenol mebutate 0.015%

Ingenol mebutate and dermasil lotion

EXPERIMENTAL

At Visit 1, ingenol mebutate 0.015% and dermasil lotion on one 25 cm2 treatment area. The treatment area receiving both ingenol mebutate 0.015% and dermasil lotion, will first apply ingenol mebutate 0.015% allow the gel to dry completely as per drug labeling on Day 1. The patient will allow at least 6 hours between the application of ingenol mebutate and dermasil lotion on Day 2 and 3. Patients will apply dermasil lotion daily on Day 2 until at least Day 8. At Day 8, the physician will reassess whether dermasil application should be continued to Day 15 or ceased. At Day 15, the physician will reassess whether dermasil application should be continued to Day 29 or ceased.

Drug: ingenol mebutate 0.015%; Other: dermasil lotion

Interventions

ingenol mebutate 0.015% DRUG

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

Ingenol mebutate alone; Ingenol mebutate and dermasil lotion

dermasil lotion OTHER

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

Ingenol mebutate and dermasil lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years old.
• Subjects must be in good general health as confirmed by the medical history.
• Subjects must be able to read, sign, and understand the informed consent
• Subjects must have two separate, relatively symmetrical 25 cm2 treatment areas on the face with at least 3-8 non-hypertrophic AKs.
• Subject must be willing to forego any other treatments on the face, including tanning bed use and excessive sun exposure while in the study.
• Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
• If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

You may not qualify if:

• Subjects with a history of melanoma anywhere on the body.
• Subjects with an unstable medical condition as deemed by the clinical investigator.
• Subjects with current non-melanoma skin cancer on the face.
• Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
• Subjects who have previously been treated with ingenol mebutate: on the face in the past 6 months; or outside of the study area within the past 30 days.
• Women who are pregnant, lactating, or planning to become pregnant during the study period.
• Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
• Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
• Subjects who have known allergies to any excipient in the ingenol mebutate 0.015% gel and/or dermasil lotion.
• Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
• Subjects who have received any of the following within 90 days prior to study treatment initiation:
• interferon or interferon inducers
• cytotoxic drugs
• immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
• oral or parenteral corticosteroids

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• LEO Pharma: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chair Dermatology

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)