Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

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


We plan to treat 20 subjects. Each qualifying subject will have at least 4-8
non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be
treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day
1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize
the once daily for three days regimen for both cycles. For the first cycle of study
application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1
baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale
(VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and
photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15,
in which LSR will be assessed and photographs taken. Approximately four weeks later, a
second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied
to the same treatment area on the face or scalp. Subjects will be followed during treatment
on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR
will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken.
Post-treatment follow-up for the second cycle of application will occur on day 36, day 43,
and day 56. During these post-treatment follow-up visits LSR and photographs will be taken.
LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29
and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual
analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Degree of Irritation after two cycles of ingenol mebutate

Outcome Description:

To evaluate the degree of irritation, as measured by local skin reactions (LSR), after a second cycle of ingenol mebutate gel to the face or scalp through photography assessed by a blinded observer.

Outcome Time Frame:

up to 1 year

Safety Issue:

Yes

Principal Investigator

Mark Lebwohl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Icahn School of Medicine at Mount Sinai

Authority:

United States: Food and Drug Administration

Study ID:

GCO 13-0026

NCT ID:

NCT01836367

Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Face
  • Scalp
  • Ingenol Mebutate
  • Keratosis
  • Keratosis, Actinic

Name

Location

Icahn School of Medicine at Mount Sinai New York, New York  10029