Actinic Keratosis Clinical Trial
Official title:
A Randomized Study to Evaluate the Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization Compared to Cryotherapy
The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150
mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or
scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of
each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the
treatment of actinic keratosis and their field cancerization.
Study details:
This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II,
located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the
inclusion criteria will be enrolled in the study by the investigators in the three different
centers mentioned above.
The investigators will assess the effect of treatment by confocal microscopy and digital
dermoscopy. The investigator will acquire images of selected areas of the face and scalp
before and after treatment. Data will be collected and analyzed by the coordinating centre.
Procedure for the study:
Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150
micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited;
evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The
measurements will be carried out at time 0, after 1 month and 6 months. The investigator must
fill out a form for each subject at the beginning (day 0), after 1 month and at the end of
the study (after 6 months). The subject must complete a questionnaire at the beginning (day
0), after 1 month and at the last follow-up visit (after 6 months).
Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the
percentage reduction in actinic keratoses and the damage of the cancerous area in the two
selected areas treated with ingenol mebutate gel or cryotherapy, respectively.
Adverse / side events will be collected at each visit by the investigator and will be
contained in another form.
This study is designed to compare the efficacy of topical ingenol mebutate (150 mcg/g once
daily on a selected facial or scalp target area of 25 cm2, for 3 consecutive days) with
cryosurgery (applied for a freeze time of 5 seconds, on each lesion included in an area of 25
cm2 on face or scalp)
This is a national, post-marketing (phase 4), on label, interventional, randomized trial.
Subjects will attend a screening visit where they will be assessed for eligibility.
Two areas of treatment in the same patient have to be identified (e.g. scalp and cheek or two
different part of the balding scalp), than these two areas will be randomized in a 2:1 ratio:
one will be treated with cryosurgery and the other one with Picato Gel.
The cryosurgery will be performed in the same day during the visit (1 application for a
freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp)
Picato gel 150 mcg will be applied at home by the patient, according to current indication
(RCP: 3 consecutive days for a total of three application in an area of 25 cm2) Subjects will
be followed for 24 weeks (about 6 months) after the cryosurgery application (Visit 1).
Adverse events and patient compliance will be recorded 7 days after cryosurgery application
and 5 days after first Picato gel application (Visit 2). The number of AKs present within the
treatment areas will be counted at Visit 1 (Baseline AK count) and at Visits 3 - 4 (AKcount).
The data obtained will provide information on the effect of Picato gel versus Cryosurgery on
recurrence rate of AKs.
Furthermore, the trial will also provide data on the effect of Picato gel versus Cryosurgery
on the appearance rate of new AKs.
The final results for all subjects will be included in a Final Clinical Study Report in the
original submission. This includes final results for all primary and secondary endpoints as
well as 6-month recurrence and Adverse Event data.
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