Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385340
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-02
Brief Title:
Investigation of the Effect of Lipikar Baume APM
Sponsor:
CentroDerm GmbH
Organization:
CentroDerm GmbH
Study Overview
Official Title:
Investigation of the Effect of Lipikar Baume APM on Skin Barrier Microbiome and AKASI of Participants with Actinic Keratoses and Field Cancerization of the Forearms and Hands
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Application of Lipikar Baume APM 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
Its 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 inclusionexclusion criteria
A total of 20 subjects will be enrolled
The study design consists in 4-week evaluation period with 2 visits per subject ScreeningBaseline Day 0 Day 28 end of Lipikar Baume APM application
Its 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 inclusionexclusion criteria
A total of 20 subjects will be enrolled
The study design consists in 4-week evaluation period with 2 visits per subject ScreeningBaseline Day 0 Day 28 end of Lipikar Baume APM application
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None