NCT02990221

Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy

Completed Phase 4 Last updated 24 September 2019

What this trial tests

Phase 4 trial testing Ingenol mebutate in Actinic Keratosis in 50 participants. Completed in 30 July 2018.

Timeline

12 April 2017

Primary endpoint
30 April 2018

30 July 2018

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	12 April 2017
Primary completion	30 April 2018
Estimated completion	30 July 2018
Sites	1 location across Italy

Drugs / interventions tested

• Ingenol mebutate (INGENOL MEBUTATE) — full drug profile →
• cryotherapy (CRYOTHERAPY) — full drug profile →

Conditions studied

• Actinic Keratosis — all drugs for Actinic Keratosis →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Why Is Wnt/β-Catenin Not Yet Targeted in Routine Cancer Care?
   de Pellegars-Malhortie A, Picque Lasorsa L, Mazard T, Granier F, et al · · 2024 · cited 12× · PMID 39065798 · DOI 10.3390/ph17070949