Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment with Ingenol Mebutate Gel, 0.05%A phase 1 trialA multi-centre, single arm, open-label, 8-week trial

Phase 1

• Conditions: L57.0; Actinic keratosis

• Registration Number: DRKS00007918
• Lead Sponsor: EO Pharma GmbH

Brief Summary

The observed agreement between the clinical- and the two pathologists’ histological assessment in clearance of single AK was 81.9%. Most AK lesions treated with ingenol mebutate had clearance of single AK at Week 8: 85.2% according to the clinical assessment, 81.5% and 80.6% according to the pathologists’ histology assessments. Ingenol mebutate treatment was generally well tolerated and no safety concerns were identified.

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-03-13
• Study Start: 2015-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Following verbal and written information about the
trial, subject must provide informed consent documented
by signing the Informed Consent Form (ICF)
prior to any trial-related procedures
2. Subjects with 5-9 clinically typical, visible and
discrete AKs within a contiguous 25 cm2 treatment
areas on the trunk and extremities except the back of
the hand.
3. Actinic keratosis should be confirmed by histopathology
of one of the AKs prior to inclusion.

Exclusion Criteria

1. Selected treatment areas:
• within 5 cm of an incompletely healed wound
• within 10 cm of a suspected basal cell carcinoma
(BCC) or squamous cell carcinoma (SCC)
2. Selected treatment area lesions that have atypical
clinical appearance (e.g., hypertrophic, hyperkeratotic
or cutaneous horn).
3. History or evidence of skin conditions other than the
trial indication that would interfere with evaluation of
the trial medication in the selected treatment area
(e.g., eczema, unstable psoriasis, xeroderma pigmentosum).
4. Use of cosmetic or therapeutic products and procedures
which could interfere with the assessments of
the treatment area
5. Clinical diagnosis/history or evidence of any medical
condition that would expose a subject to an undue
risk of a significant AE or interfere with assessments
of safety and efficacy during the course of the trial, as
determined by the investigator’s clinical judgment.
6. Anticipated need for hospitalisation or out-patient
surgery during the first 15 days after the first trial
medication application. Note that cosmetic/
therapeutic procedures are not excluded if they
fall outside of the criteria detailed in Prohibited
Therapies or Medications
7. Known sensitivity or allergy to any of the ingredients
in ingenol mebutate gel
8. Presence of sunburn within the selected treatment
areas
9. Current enrolment or participation in any other
interventional clinical trial within 30 days of entry
into this trial.
10. Subjects previously enrolled in this trial.
11. Female subjects who are breastfeeding.
12. Subjects who are institutionalised by court order
13. In the opinion of the investigator, the subject is
unlikely to comply with the Clinical Study Protocol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate an adequate predictive value of the clinical diagnosis of clearance of Actinic Keratosis (AK) after the treatment with ingenol mebutate using histopathological examination as the standard at Day 57

Secondary Outcome Measures

Name	Time	Method
To determine the efficacy in terms of complete clearance of AKs in the selected treatment area and histological clearance of the pre-identified lesion. To evaluate the safety of ingenol mebutate gel at Day 57.