Investigation of the Effect of Lipikar Baume AP+M

Launched by CENTRODERM GMBH · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a moisturizer called Lipikar Baume AP+M on patients with actinic keratoses (AK), which are rough, scaly patches on the skin caused by sun damage. The main goal is to see how this product affects skin health by measuring things like how well the skin keeps moisture in and any changes in skin bacteria. Participants in the trial will apply the moisturizer at least twice a day for four weeks and will have two visits to the study center in Germany, one at the start and another at the end of the study.

To be eligible for this study, participants need to be adults over 18 years old with at least four actinic keratoses on their forearms or hands. They should be in good health and not have had any other treatments for their skin condition in the past three months. Participants will need to provide informed consent to join, and the study aims to recruit a total of 20 individuals. This is a great opportunity for those looking for potential new treatments for actinic keratoses while contributing to important research.

Gender

ALL

Eligibility criteria

• 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