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
Lipikar Baume AP+M
Keratosis+3
+ Neoplasms
+ Precancerous Conditions
Supportive Care Study
Summary
Study start date: April 23, 2024
Actual date on which the first participant was enrolled.This clinical trial focuses on understanding how a skincare product, Lipikar Baume AP+M, affects the skin's protective barrier, water loss, and the community of microorganisms living on the skin. The study targets adults with actinic keratoses, which are rough, scaly patches on the skin caused by sun damage, on their forearms and hands. These conditions, if untreated, can lead to skin cancer, hence finding effective skin treatments is important to improve skin health and potentially prevent further damage. Participants will apply Lipikar Baume AP+M to one of their arms at least twice a day for four weeks. The study involves two visits, one at the start and one at the end of the four weeks, to observe any changes. During these visits, researchers will assess changes in the skin's barrier function, water loss, and microbial balance. The study is conducted in a controlled, blinded manner, meaning the evaluators do not know which arm received the treatment, ensuring unbiased results. This helps in understanding the product's effectiveness and safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location