Effect of Cream Paste Containg Pleuran on Selected Skin Dermatoses (Neonatal Pustulosis, Diaper Dermatitis, Perioral Dermatitis).
NCT07479004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-03-23
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).
Conditions
- Diaper Dermatitis
- Perioral Dermatitis
- Neonatal Pustulosis
- Periorificial Dermatitis
- Erythema
Interventions
- OTHER
-
Cosmetic product: Imunoglukan P4H® ACUTE! cream-paste
cream-paste based on pleuran, zinc oxide, hyaluronic acid and vitamin E
Sponsors & Collaborators
-
Pleuran, s.r.o.
lead INDUSTRY
Principal Investigators
-
Karolina 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
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Slovakia
Study Locations
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