Treatment of Actinic Keratoses (AK) on the Face

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02411851
• Date of registration: 03/04/2015
• Prospective Registration: No
• Primary sponsor: Icahn School of Medicine at Mount Sinai
• Public title: Treatment of Actinic Keratoses (AK) on the Face
• Scientific title: An Investigator-Initiated Study to Assess the Efficacy and Degree of Irritation of Ingenol Mebutate 0.015% Gel and Dermasil Lotion Versus Ingenol Mebuate 0.015% Alone in the Treatment of Actinic Keratoses (AK) on the Face.
• Date of first enrolment: March 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02411851
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Mark Lebwohl, MD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- topical corticosteroids if greater than 2 gm/day

- any dermatologic procedures or surgeries on the study area (including any AK
treatments)

- Subjects who have used any topical prescription medications on the study area within
30 days prior to study treatment initiation.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Actinic Keratoses

Intervention(s)

Other: dermasil lotion

Drug: ingenol mebutate 0.015%

Primary Outcome(s)

Local Skin Reaction (LSR) [Time Frame: up to day 57]

Secondary Outcome(s)

AK lesion count [Time Frame: baseline and day 57]

Visual Analog Scale (VAS) Survey [Time Frame: baseline and day 57]

Secondary ID(s)

GCO 14-1319

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LEO Pharma