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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Degree of Irritation after two cycles of ingenol mebutate
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.
up to 1 year
Mark Lebwohl, MD
Icahn School of Medicine at Mount Sinai
United States: Food and Drug Administration
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