NCT07479004

Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).

Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Pleuran, s.r.o. · Industry
• Sex: All
• Age: 3 Weeks
• Healthy volunteers: Not accepted

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)

Conditions

• Diaper Dermatitis
• Perioral Dermatitis
• Neonatal Pustulosis
• Periorificial Dermatitis
• Erythema

Interventions

Type	Name	Description
OTHER	Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste	cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2026-03-18
• Last updated: 2026-03-23

Locations

15 sites across 1 country: Slovakia