A study to evaluate the efficacy of ingenol mebutate on precancerosis and its contigous area compared to cryotherapy

Phase 1

• Conditions: actinic keratoses and field cancerization; MedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-005820-24-IT
• Lead Sponsor: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Current diagnosis of AK, with =2 lesions of grade I and/or II located in two different anatomical districts (within a contiguous 25 cm2 area on the face, scalp or forehead);
- Male = 18 years of age
- Female = 60 years of age ;
•Skin type I or II according to Fitzpatrick;
•Patient has confirmed his/her willingness to participate in this study after being informed of all aspects of the study that are relevant to his/her decision to participate, by signing and dating the approved informed consent form, according to ICH and local laws.
The 25 cm2 contiguous treatment areas could be of any shape, e.g. 5 cm x 5 cm, 2 cm x 12.5 cm, 3 cm x 8.3 cm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Has received any therapy for AK within the past 3 months
•Has AK of grade III
•Has currently a skin cancer or shows an early stage of skin cancer;
•Has another skin disease that requires treatment with other medications in the AK area or in distance of 3 cm;
•Use of cosmetic or therapeutic products and procedures which could interfere with assessments of the treatment area;
•Immunosuppressive therapies or current treatment for cancer;
•Clinically unstable medical condition;
•High risk group for HIV infection or presentation of other infectious diseases (HAV, HBV, HCV, TBC, etc);
•Allergies to the tested gel (ingenol mebutate and eccipients);
•Pregnancy and breastfeeding;
•Psychiatric disease that may interfere with follow-up of study procedures;
•Participation in other clinical trials up to 30 days prior to day 1 of the study;
•Patient is, for any reason, considered by the investigator to be an unsuitable candidate for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the clinical efficacy of ingenol mebutate gel versus cryosurgery in terms of number of AKs showing complete response and the effect of the two treatments on the cancerization field as measured using reflectance confocal microscopy ;Secondary Objective: Patient compliance;<br>Patient assessment of local tolerability and satisfaction to treatment;<br>Cosmetic outcome<br>;Primary end point(s): At least 75% reduction in the total AK count relative to baseline<br> Reduction of subclinical AK lesions according to a RCM score<br>;Timepoint(s) of evaluation of this end point: At month 1 and month 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Absence of new lesions after a follow-up period of 6 months<br>Cosmetic outcome.<br>;Timepoint(s) of evaluation of this end point: At month 6