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).
* 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E
General outpatient clinic for children and adolescents
Banská Bystrica, Slovakia
General outpatient clinic for children and adolescents
Bratislava, Slovakia
General outpatient clinic for children and adolescents
Bratislava, Slovakia
General outpatient clinic for children and adolescents
Bratislava, Slovakia
General outpatient clinic for children and adolescents
Bratislava, Slovakia
General outpatient clinic for children and adolescents
Bratislava, Slovakia
General outpatient clinic for children and adolescents
Brezno, Slovakia
General outpatient clinic for children and adolescents
Dolný Kubín, Slovakia
General outpatient clinic for children and adolescents
Dunajská Streda, Slovakia
General outpatient clinic for children and adolescents
Košice, Slovakia
...and 5 more locations
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
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