Actively Recruiting
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
Led by CentroDerm GmbH · Updated on 2025-07-11
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with actinic keratoses (AK) lesions on their forearms and backs of hands to observe how Lipikar Baume AP+M affects skin barrier function, water loss through the skin, and changes in skin microbes. This is a randomized, evaluator-blinded study conducted in Germany, enrolling 20 adult participants with grade I to III AK lesions and similar severity on both arms. Participants will apply Lipikar Baume AP+M at least twice daily for 4 weeks on one randomly selected arm, while the other arm receives no intervention. The study includes a total of two visits: a screening/baseline visit at the start (Day 0) and a final visit at the end of the 4-week application period (Day 28). During participation, researchers will measure skin hydration, transepidermal water loss, and the severity and area of AK lesions using the AKASI score. They will also evaluate colonization by specific skin bacteria and assess skin appearance. Additional assessments include lesion counts, symptom severity, treatment satisfaction, and compliance with the application schedule. Photographs will be taken at all time points to monitor changes. The total study duration for each participant is 4 weeks.
CONDITIONS
Brief Title
Investigation of the Effect of Lipikar Baume AP+M
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, or diverse adults over 18 years old who can give consent
- Female participants must be postmenopausal, surgically sterile, or not of childbearing potential
- Signed informed consent form
- Diagnosis of at least 4 actinic keratoses (AK) lesions on the forearm and/or back of the hand on each arm
- Olsen grade I, II, or III AK lesions
- Similar severity and number of AK lesions symmetrically on both arms
- Good general health without active diseases that would exclude participation in the investigator's opinion
You will not qualify if you...
- Known intolerance to any ingredient of Lipikar Baume AP+M
- Planned AK treatment during the study period
- Treatment of AK lesions in the application area within the past 3 months (e.g., photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy)
- Suspected invasive squamous cell cancer in the application area
- Chronic wounds, erosions, infected skin, or inflammation requiring treatment other than the study product
- Suspected non-compliance with study procedures
- Systemic cancer medication or systemic 5-Fluorouracil treatment within the last 8 weeks
- Systemic immunosuppressant use within 8 weeks prior to the study
- Use of locally applied retinoids, steroids, or other prescribed external treatments in the 4 weeks before study start
- Use of products containing glycolic or alpha-hydroxy acids on the application area within the last 4 weeks
- Participation in another clinical trial currently or within the last 30 days
- Family members or colleagues of the investigator
- Any relationship with the investigator that could cause a conflict of interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants apply Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms as assigned by randomization.
Multiple visits for assessments during the treatment period
Trial Site Locations
Total: 1 location
1
CentroDerm GmbH
Wuppertal, North Rhine-Westphalia, Germany, 42287
Actively Recruiting
Research Team
T
Thomas Dirschka, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here