Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01836367
• Date of registration: 17/04/2013
• Prospective Registration: No
• Primary sponsor: Mount Sinai School of Medicine
• Public title: Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
• Scientific title: An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
• Date of first enrolment: March 2013
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01836367
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

United States

Contacts

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

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 have at least 4-8 clinically typical, visible, non-hypertrophic actinic
keratoses on the face or scalp in a 25 cm2 area.

- Subject must be willing to forego any other treatments on the face or scalp,
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.

- The second cycle of ingenol mebutate 0.015% should only be applied if the skin is
healed from the first cycle of ingenol mebutate 0.015%.

- Subjects with an unstable medical condition as deemed by the clinical investigator.

- Subjects with non-melanoma skin cancer on the face or scalp.

- 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 or scalp
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 study gel.

- 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: Both

Health Condition(s) or Problem(s) studied

Actinic Keratosis

Intervention(s)

Drug: Ingenol Mebutate 0.015%

Primary Outcome(s)

Degree of Irritation after two cycles of ingenol mebutate [Time Frame: up to 1 year]

Secondary Outcome(s)

Degree of Irritation 1 day post application of first and second cycle of ingenol mebutate [Time Frame: up to 1 year]

Secondary ID(s)

GCO 13-0026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LEO Pharma