Investigation of the Effect of Lipikar Baume AP+M

Trial Title: Investigation of the Effect of Lipikar Baume AP+M

NCT ID: NCT06385340

Condition: Actinic Keratoses

Conditions: Official terms:
Keratosis, Actinic
Keratosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Supportive Care

Masking: Single (Investigator)

Intervention:

Intervention type: Other
Intervention name: Lipikar Baume AP+M
Description: • Lipikar Baume AP+M Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme
Arm group label: Lipikar Baume AP+M

Summary: 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)).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CentroDerm GmbH

Address:
City: Wuppertal
Zip: 42287
Country: Germany

Status: Recruiting

Contact:
Last name: Thomas Dirschka, Prof. Dr. med.

Phone: 0049 (0) 202 629337 57
Email: studien@centroderm.de

Start date: April 23, 2024

Completion date: January 31, 2025

Lead sponsor:
Agency: CentroDerm GmbH
Agency class: Other

Source: CentroDerm GmbH

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06385340