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Completed

NCT Number: NCT07479004

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

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).

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Key information

Conditions

Diaper Dermatitis Dermatitis Dermatitis, Contact Dermatitis, Irritant Dermatitis, Perioral Diaper Rash Erythema Facial Dermatoses Neonatal Pustulosis Pathological Conditions, Signs and Symptoms Perioral Dermatitis Periorificial Dermatitis Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Manifestations Skin and Connective Tissue Diseases

Age range

3 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General outpatient clinic for children and adolescents, Banská Bystrica, Slovakia

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About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste

Other

cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E

Primary outcomes

  1. Clinician's Erythema Assessment

    Time frame: 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

    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)

  2. Investigator's Global Assessment (IGA)

    Time frame: 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

    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)

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1)

    Safety was monitored by number of participants with treatment-related adverse events.

  2. Tolerability of the cosmetic product

    Time frame: 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

    Tolerability was assessed by product acceptance and adherence to study treatment using a 3-point tolerability scale (0 = poor; 1 = good; 2 = excellent)

Sponsors and collaborators

Lead sponsor

Pleuran, s.r.o.

Industry

Registry information

Official study title

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

Acronym: ECESID

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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