Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Phase 1

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Ingenol mebutate gel 0.05%

• Registration Number: NCT01892137
• Lead Sponsor: LEO Pharma

Brief Summary

The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-23
• Study First Submitted QC: 2013-06-30
• Study Start: 2013-07
• Study First Posted: 2013-07-04
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Must be male or female and at least 18 years of age.
• Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
• Ability to provide informed consent
• Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
• AK should be confirmed by histopathology of one of the AK's prior to inclusion

Exclusion Criteria

• location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
• undergone Cosmetic or therapeutic procedures
• use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
• use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
• treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
• treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
• use of systemic retinoids
• those who are currently participating in any other interventional clinical trial
• females who are pregnant or are breastfeeding
• those known or suspected of not being able to comply with the requirements of the protocol or provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label active	Ingenol mebutate gel 0.05%	-

Primary Outcome Measures

Name	Time	Method
Clearance of AK	8 weeks	The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).

Secondary Outcome Measures

Name	Time	Method
Complete clearance of AKs in the Selected Treatment Area	8 weeks	Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK.

Trial Locations

Locations (10)

Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd; 🇩🇪 Augsburg, Germany

Medizinisches Zentrum Bonn Friedensplatz; 🇩🇪 Bonn, Germany

St John of God Dermatology; 🇦🇺 Subiaco, Western Australia, Australia

Southderm Pty Ltd; 🇦🇺 Kogarah, New South Wales, Australia

Melanoma Institute Australia; 🇦🇺 north Sydney, New South Wales, Australia

Burswood Dermatology; 🇦🇺 Victoria Park, Western Australia, Australia

South East Dermatology Centre; 🇦🇺 Carina Heights, Queensland, Australia

The Skin Centre; 🇦🇺 Benowa, Queensland, Australia

Collegium Medicum Berlin GmbH; 🇩🇪 Berlin, Germany

Hautarztpraxis Prof. Dr. med. C. Termeer; 🇩🇪 Stuttgart, Germany