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

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

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).

Study Overview

• Status: Completed
• Conditions: Erythema; Perioral Dermatitis; Diaper Dermatitis; Neonatal Pustulosis; Periorificial Dermatitis
• Intervention / Treatment: Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Banská Bystrica, Slovakia, 974 01
    • General outpatient clinic for children and adolescents
  • Bratislava, Slovakia, 821 01
    • General outpatient clinic for children and adolescents
  • Bratislava, Slovakia, 821 07
    • General outpatient clinic for children and adolescents
  • Bratislava, Slovakia, 841 01
    • General outpatient clinic for children and adolescents
  • Bratislava, Slovakia, 841 07
    • General outpatient clinic for children and adolescents
  • Bratislava, Slovakia, 851 01
    • General outpatient clinic for children and adolescents
  • Brezno, Slovakia, 977 01
    • General outpatient clinic for children and adolescents
  • Dolný Kubín, Slovakia, 026 01
    • General outpatient clinic for children and adolescents
  • Dunajská Streda, Slovakia, 929 01
    • General outpatient clinic for children and adolescents
  • Košice, Slovakia, 04001
    • General outpatient clinic for children and adolescents
  • Martin, Slovakia, 036 01
    • General outpatient clinic for children and adolescents
  • Ružomberok, Slovakia, 034 01
    • General outpatient clinic for children and adolescents
  • Trnava, Slovakia, 917 01
    • General outpatient clinic for children and adolescents
  • Zlaté Moravce, Slovakia, 95301
    • General outpatient clinic for children and adolescents
  • Žiar nad Hronom, Slovakia, 96501
    • General outpatient clinic for children and adolescents

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• signed informed consent
• age from 3 weeks
• at least one of the following diagnoses: perioral dermatitis, diaper dermatitis, neonatal pustulosis

Exclusion Criteria:

• refused to sign informed consent
• application of topical corticosteroids, antihistamines, other immunomodulatory preparations (e.g. beta-glucans) at time of inclusion
• using of oral corticosteroids, antihistamines at time of inclusion
• known intolerance to any ingredients contained in the investigational product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group	Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste; cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician's Erythema Assessment	Clinical assessment of erythema using a 5-point severity scale (0 = no erythema; 1 = very mild erythema: light pink; 2 = mild erythema: pink; 3 = moderate erythema: red; 4 = severe erythema: intense red)	from the enrolment (day 1;V0) to complete recovery from erythema (latest on day 14; V1) at each study visit Evaluations: - initial visit (V0) - day of enrolment - control visit (V1) - after complete recovery from erythema or max. 14 days from enrolment
Investigator's Global Assessment (IGA)	Overall severity and improvement of selected dermatoses (diaper dermatitis, perioral dermatitis, neonatal dermatitis) evaluated by Investigator's global assessment (IGA) using a 6-point scale (-1 = worsening; 0 = no response; 1 = mild response; 2 = moderate response; 3 = excellent response; 4 = complete response)	from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) initial visit (V0) - day of enrolment control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Safety was monitored by number of participants with treatment-related adverse events.	from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1)
Tolerability of the cosmetic product	Tolerability was assessed by product acceptance and adherence to study treatment using a 3-point tolerability scale (0 = poor; 1 = good; 2 = excellent)	from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1) Evaluation at control visit (V1) - after complete recovery from erythema or maximum 14 days from enrolment

Collaborators and Investigators

• Sponsor: Pleuran, s.r.o.
• Investigators: Principal Investigator: Karolina Vorcakova, MD., PhD., Department of Dermatovenerology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Hospital Martin, Kollarova 2, 036 59 Martin, Slovakia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: beta-glucan; perioral dermatitis; diaper dermatitis; zinc oxide; pleuran; neonatal pustulosis; periorificial dermatitis; overall improvement of erythema severity; reduction of erythema severity
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Irritant; Dermatitis, Contact; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Facial Dermatoses; Erythema; Diaper Rash; Dermatitis, Perioral
• Other Study ID Numbers: ECESID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No