NCT06385340

Investigation of the Effect of Lipikar Baume AP+M

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: CentroDerm GmbH · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)).

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
OTHER	Lipikar Baume AP+M	• 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

Timeline

• Start date: 2024-04-23
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2024-04-26
• Last updated: 2025-07-11

Locations

1 site across 1 country: Germany