Diaper Dermatitis, Erythema, Neonatal Pustulosis, Perioral Dermatitis, Periorificial Dermatitis
Conditions
Keywords
pleuran, beta-glucan, neonatal pustulosis, diaper dermatitis, perioral dermatitis, zinc oxide, periorificial dermatitis, overall improvement of erythema severity, reduction of erythema severity
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).
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)
Interventions
OTHERCosmetic product: Imunoglukan P4H® ACUTE! cream-paste
cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E
Sponsors
Pleuran, s.r.o.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician's Erythema Assessment | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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. |
| 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 | Tolerability was assessed by product acceptance and adherence to study treatment using a 3-point tolerability scale (0 = poor; 1 = good; 2 = excellent) |
Countries
Slovakia
Contacts
PRINCIPAL_INVESTIGATORKarolina 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
Outcome results
None listed