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Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

NCT02424305•LEO Pharma

View on ClinicalTrials.gov

Summary

This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin. There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects with 15 or more clinically typical, visible and discrete AKs on either:
•* Full face (corresponding to a treatment area of at least 250 cm2). If subjects have a beard they must shave no later than the day before the first drug application.
•* A contiguous area of approximately 250 cm2 on the arm between wrist and shoulder.
•* Balding scalp (corresponding to a treatment area of approximately 250 cm2). Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK assessments are not compromised.
•2. Subject at least 18 years of age.
•3. Female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
•4. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Exclusion Criteria

•1. Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)
•* within 5 cm of an incompletely healed wound.
•* within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
•2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
•3. Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns)and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Locations (1)

Pflugerville Dermatology Clinical Research

Pflugerville, Texas, United States

Key Dates

Start Date

May 1, 2015

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Actinic Keratosis

Interventions

LEO 43204 gel 0.018%

DRUG

LEO 43204 gel 0.1%

DRUG

LEO 43204 gel 0.037%

DRUG

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

NCT06778434

Actinic KeratosisImipramine+1 more

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RECRUITING

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

NCT06648447

Actinic Keratosis (AK)

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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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Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

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