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Investigation of the Effect of Lipikar Baume AP+M | Clinical Trials | Clareo Health

RECRUITINGNA

Investigation of the Effect of Lipikar Baume AP+M

Investigation of the Effect of Lipikar Baume AP+M on Skin Barrier, Microbiome and AKASI of Participants With Actinic Keratoses and Field Cancerization of the Forearms and Hands

NCT06385340•CentroDerm GmbH

View on ClinicalTrials.gov

Summary

Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms. It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria. A total of 20 subjects will be enrolled. The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male, female, diverse persons (\> 18yo) who are capable of giving consent
•Signed informed consent
•Diagnosis of at least 4 actinic keratoses of the the forearm and/or back of the hand (each arm)
•Olsen grade I, II and/or III
•Subjects with similar severity and number of AKs on each side symmetrically
•The study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

Exclusion Criteria

•Known or documented intolerance to any of the ingredients of Lipikar Baume AP+M
•Any planned AK treatment during the study
•Treatment of actinic keratoses in the application area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
•Suspected invasive squamous cell cancer in the application area
•Chronic wounds, erosions, pre-existing infected skin or inflammation which, in the opinion of the investigator, are in need of treatment other than the study product
•Suspected non-compliance
•Current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil
•Any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)
•Locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study that, in the opinion of the study physician, necessitate exclusion
•Products containing glycolic or alpha-hydroxy acids applied locally in the application area in the last 4 weeks
+4 more criteria

Locations (1)

CentroDerm GmbH

Wuppertal, North Rhine-Westphalia, Germany

Key Dates

Start Date

April 23, 2024

Primary Completion Date

October 30, 2025

Completion Date

November 30, 2025

Last Updated

July 11, 2025

Enrollment

ESTIMATED participants

Conditions

Actinic Keratoses

Interventions

Lipikar Baume AP+M

OTHER

Contacts

Thomas Dirschka, Prof. Dr.

CONTACT

+49 (0) 202 - 62 933 70 info@centroderm.de

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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: July 11, 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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Investigation of the Effect of Lipikar Baume AP+M

Inclusion Criteria

Exclusion Criteria

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