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

COMPLETEDPHASE1

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

NCT01892137•LEO Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (10)

Southderm Pty Ltd

Kogarah, New South Wales, Australia

Melanoma Institute Australia

North Sydney, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

South East Dermatology Centre

Carina Heights, Queensland, Australia

St John of God Dermatology

Subiaco, Western Australia, Australia

Burswood Dermatology

Victoria Park, Western Australia, Australia

Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd

Augsburg, Germany

Collegium Medicum Berlin GmbH

Berlin, Germany

Medizinisches Zentrum Bonn Friedensplatz

Bonn, Germany

Hautarztpraxis Prof. Dr. med. C. Termeer

Stuttgart, Germany

Key Dates

Start Date

July 1, 2013

Primary Completion Date

March 1, 2014

Completion Date

May 1, 2014

Last Updated

February 24, 2025

Enrollment

137

ACTUAL participants

Conditions

Actinic Keratosis

Interventions

Ingenol mebutate gel 0.05%

DRUG

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

NCT06778434

Actinic KeratosisImipramine+1 more

View study

RECRUITING

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

NCT06648447

Actinic Keratosis (AK)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans

Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns

The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Trial to Investigate GZ21T in Healthy Volunteers

Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis