Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07479004
Brief Summary:
In this multicentre, prospective clinical research conducted in outpatient healthcare facilities, the investigators studied the effect of novel cosmetic product Imunoglukan P4H® ACUTE! cream paste in children with neonatal pustulosis, diaper dermatitis or perioral dermatitis. The main endpoints of the study were focused on objective evaluation of erythema severity and overall improvement of selected dermatoses.
Participants enrolled in the study applied Imunoglukan P4H® ACUTE! cream paste at least 2-3 times daily (or as needed) in an adequate amount to the affected area for a maximum of 2 weeks (without other treatment).
Detailed Description:
* Design: Multicentre, prospective, open-label study
* Centres: 20 outpatient healthcare facilities in Slovakia (1 Department of Dermatology, 19 general outpatient clinic for children and adolescents)
* Patients: 110 children from 3 weeks of age with selected skin dermatoses (neonatal pustulosis, diaper dermatitis, perioral dermatitis)
* Treatment: Imunoglukan P4H® ACUTE! cream paste applied 2-3 times a day or as needed (without other treatment)
* Study period: until erythema disappears or for a maximum of 14 days
* Primary endpoints:
* severity of erythema according to 5-point scale (Clinician's Erythema Assessment - CEA)
* overall severity and improvement of selected dermatoses according to 6-point scale (Investigator's Global Assessment - IGA)
* Secondary endpoint:
* tolerability of novel cosmetic product (Clinician's Assessment of Tolerability)
Study:
NCT07479004
Study Brief:
Protocol Section:
NCT07479004