Effect of Lipikar Baume AP+M on Actinic Keratoses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the application of Lipikar Baume AP+M on patients with actinic keratoses, focusing on its effects on skin barrier function, transepidermal water loss, and microbial changes. Participants will apply the product at least twice daily for four weeks, with evaluations conducted at the start and end of the treatment period. The study is randomized and evaluator-blinded, involving 20 adult subjects with specific inclusion and exclusion criteria. It aims to provide insights into the efficacy of the treatment for skin conditions related to sun damage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male, female, diverse persons (\> 18yo) who are capable of giving consent
* Female patients are eligible if the subject is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation \>12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
* 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
* Participation in another clinical trial
* Participation in a clinical study within the last 30 days
* Family members or colleagues of the investigator
* Participant is in a position or has a relationship with the investigator that presents a potential conflict of interest

Where it's running

• CentroDerm GmbH
  Wuppertal, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Thomas Dirschka, Prof. Dr. — CentroDerm GmbH
• Study coordinator: Thomas Dirschka, Prof. Dr.
• Email: info@centroderm.de
• Phone: +49 (0) 202 - 62 933 70

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using laser treatment to protect older skin from skin cancer

  This study tests if a special laser treatment can help older adults with actinic keratosis reduce their chances of developing skin cancer in the future.

  Recruiting Wright State University · Dayton, Ohio · NCT03906253

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.