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Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2 on the Chest in Subjects With Actinic Keratosis

NCT01820260•LEO Pharma

View on ClinicalTrials.gov

Summary

To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be competent to understand the nature of the trial and provide informed consent
•Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest
•Subject at least 18 years of age
•Female subjects must be of either:
•1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
•2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy
•Female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion

Exclusion Criteria

•Location of the treatment area (full face, full balding scalp or chest)
•* within 5 cm of an incompletely healed wound,
•* within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC
•Prior treatment with ingenol mebutate gel within the treatment area
•Lesions in the treatment areas that have:
•* atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
•* recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions
•History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
•Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
•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
+8 more criteria

Locations (1)

Laser & Skin Surgery Center of Inidana

Carmel, Indiana, United States

Key Dates

Start Date

April 1, 2013

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

March 13, 2025

Enrollment

395

ACTUAL participants

Conditions

Actinic Keratosis

Interventions

Ingenol mebutate gel

DRUG

placebo

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: March 13, 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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Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

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

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis