An interventional study of Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste in Diaper Dermatitis, Perioral Dermatitis and Neonatal Pustulosis, sponsored by Pleuran, s.r.o.. Completed at 15 sites in Slovakia. Open to participants aged 3 Weeks and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Pleuran, s.r.o. · Not applicable, Interventional, and Treatment
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).
38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.
This study's enrollment of 110 is above the median of 92 across 28 interventional studies indexed under Diaper Rash.
Browse Diaper Rash studies →Pleuran, s.r.o. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste
cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E
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)
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
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)
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
Incidence of Treatment-Emergent Adverse Events
Safety was monitored by number of participants with treatment-related 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
Tolerability was assessed by product acceptance and adherence to study treatment using a 3-point tolerability scale (0 = poor; 1 = good; 2 = excellent)
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
Plan to share: Yes
Supporting information: Study protocol
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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