Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy
Status:
Completed
Trial end date:
2018-07-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Second University of Naples University of Campania "Luigi Vanvitelli"