Diaper DermatitisECESIDNCT07479004
Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).
A study testing Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste in people with Diaper Dermatitis and Perioral Dermatitis, run by Pleuran, s.r.o. at 15 sites in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 weeks and older
- Conditions the study is for
- Diaper Dermatitis, Perioral Dermatitis, Neonatal Pustulosis
- What is being tested?
- Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 15 sitesSlovakia
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- signed informed consent
- age from 3 weeks
- at least one of the following diagnoses: perioral dermatitis, diaper dermatitis, neonatal pustulosis
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Slovakia15 sites
General outpatient clinic for children and adolescents
Banská Bystrica, 974 01
General outpatient clinic for children and adolescents
Bratislava, 821 01
General outpatient clinic for children and adolescents
Bratislava, 821 07
General outpatient clinic for children and adolescents
Bratislava, 841 01
General outpatient clinic for children and adolescents
Bratislava, 841 07
General outpatient clinic for children and adolescents
Bratislava, 851 01
General outpatient clinic for children and adolescents
Brezno, 977 01
General outpatient clinic for children and adolescents
Dolný Kubín, 026 01
General outpatient clinic for children and adolescents
Dunajská Streda, 929 01
General outpatient clinic for children and adolescents
Košice, 04001
General outpatient clinic for children and adolescents
Martin, 036 01
General outpatient clinic for children and adolescents
Ružomberok, 034 01
General outpatient clinic for children and adolescents
Trnava, 917 01
General outpatient clinic for children and adolescents
Žiar nad Hronom, 96501
General outpatient clinic for children and adolescents
Zlaté Moravce, 95301
About this study
Official title: 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).
Read the 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
- Being tested
- Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste
- Keywords
- pleuran, beta-glucan, neonatal pustulosis, diaper dermatitis, perioral dermatitis, zinc oxide, periorificial dermatitis, overall improvement of erythema severity, reduction of erythema severity
- Medical subject headings
- Diaper Rash, Dermatitis, Perioral, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic product: Imunoglukan P4H® ACUTE! cream-pasteOther
cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Not described Receives: Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Safety was monitored by number of participants with treatment-related adverse events.
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pleuran, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karolina Vorcakova, MD., PhD., Principal investigator, Department of Dermatovenerology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Hospital Martin, Kollarova 2, 036 59 Martin, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479004
- Sponsor's protocol ID
- ECESID
- Acronym
- ECESID
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.
- ClinicalTrials.gov ID
- NCT07479004
- Acronym / sponsor ID
- ECESID / ECESID
- Conditions
- Diaper Dermatitis, Perioral Dermatitis, Neonatal Pustulosis, Periorificial Dermatitis, Erythema
- Keywords
- pleuran, beta-glucan, neonatal pustulosis, diaper dermatitis, perioral dermatitis, zinc oxide, periorificial dermatitis, overall improvement of erythema severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Pleuran, s.r.o.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste |
Who may qualify
- Ages
- 3 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- age from 3 weeks
- at least one of the following diagnoses: perioral dermatitis, diaper dermatitis, neonatal pustulosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic product: Imunoglukan P4H® ACUTE! cream-pastecream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E | Other | Active group |
Primary outcome
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)
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)
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: from the enrolment (day 1; V0) to complete recovery from erythema (latest on day 14; V1)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karolina Vorcakova, MD., PhD. principal investigator
Department of Dermatovenerology, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, University Hospital Martin, Kollarova 2, 036 59 Martin, Slovakia
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste in people with Diaper Dermatitis and Perioral Dermatitis, run by Pleuran, s.r.o. at 15 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.