Actively Recruiting
Investigation of the Effect of Lipikar Baume AP+M
Led by CentroDerm GmbH · Updated on 2025-07-11
20
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)).
CONDITIONS
Official Title
Investigation of the Effect of Lipikar Baume AP+M
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, diverse persons older than 18 years who can give consent
- Female participants must not be women of childbearing potential or must be postmenopausal or surgically sterile
- Signed informed consent
- At least 4 actinic keratoses lesions on the forearm and/or back of the hand on each arm
- Olsen grade I, II, or III actinic keratoses
- Similar severity and number of actinic keratoses symmetrically on both arms
- Good general health with no active diseases that would exclude participation according to the investigator
You will not qualify if you...
- Known intolerance to any ingredients of Lipikar Baume AP+M
- Planned treatment for actinic keratoses during the study
- Treatment for actinic keratoses in the application area within the past 3 months
- Suspected invasive squamous cell cancer in the application area
- Chronic wounds, infections, or inflammation in the application area requiring treatment other than the study product
- Suspected non-compliance
- Systemic cancer medication or 5-Fluorouracil within the last 8 weeks
- Systemic immunosuppressant therapy within the last 8 weeks
- Use of locally applied retinoids, steroids, or other prescribed topical treatments within 4 weeks before the study
- Use of products with glycolic or alpha-hydroxy acids on the application area in the last 4 weeks
- Participation in another clinical trial or study 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
Trial Site Locations
Total: 1 location
1
CentroDerm GmbH
Wuppertal, North Rhine-Westphalia, Germany, 42287
Actively Recruiting
Research Team
T
Thomas Dirschka, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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