Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07479004
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).
Sponsor:
Pleuran, s.r.o.
Organization:
Study Overview
Official Title:
Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.
Status:
COMPLETED
Status Verified Date:
2024-04
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:
ECESID
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).
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)
* 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 Oversight
Has Oversight DMC:
False
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?: