Effect of Lipikar Baume AP+M on Actinic Keratoses
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
NA · CentroDerm GmbH · NCT06385340
This study is testing whether using Lipikar Baume AP+M can help improve skin health in adults with actinic keratoses caused by sun damage.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CentroDerm GmbH (network) |
| Locations | 1 site (Wuppertal, North Rhine-Westphalia) |
| Trial ID | NCT06385340 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with at least four actinic keratoses on their forearms or back of hands.
Not a fit: Patients with known intolerance to the ingredients of Lipikar Baume AP+M or those undergoing other treatments for actinic keratoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of actinic keratoses and enhance skin health for affected patients.
How similar studies have performed: While this specific approach may be novel, similar studies have shown promise in improving skin conditions through topical treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuppertal, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Actinic Keratoses