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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach

1 country

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

May 1, 2024

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed

Last Updated

March 23, 2026

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 13, 2026

Last Update Submit

March 18, 2026

Conditions

Diaper Dermatitis Perioral Dermatitis Neonatal Pustulosis Periorificial Dermatitis Erythema

Keywords

pleuranbeta-glucanneonatal pustulosisdiaper dermatitisperioral dermatitiszinc oxideperiorificial dermatitisoverall improvement of erythema severityreduction of erythema severity

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

Incidence of Treatment-Emergent Adverse Events
from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1)
Tolerability of the cosmetic product
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

Study Arms (1)

Active group

EXPERIMENTAL

Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste

Interventions

Cosmetic product: Imunoglukan P4H® ACUTE! cream-pasteOTHER

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

Active group

Eligibility Criteria

Age3 Weeks+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

refused to sign informed consent
known intolerance to any ingredients contained in the investigational product

Contact the study team to confirm eligibility.