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TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Sponsor: ICIM International S.r.l.
Summary
This clinical study aims to evaluate the effects of using the cosmetic product TRIDERM D.S. Crema Normalizzante in children aged 0 to 3 years with neonatal hyperseborrhea ("cradle cap"), potentially associated with manifestations of mild-to-moderate seborrheic dermatitis. The study will assess whether use of the product is associated with an improvement in the clinical signs of the condition, particularly scaling and erythema, and will evaluate its cutaneous tolerability. Caregiver-perceived improvement, as well as additional dermatological, photographic, and instrumental assessments, will also be considered.
Official title: Prospective, Interventional, Single-Center, Single-Arm Clinical Study to Evaluate the Clinical Improvement of Neonatal Hyperseborrhea ("Cradle Cap"), Including Potential Cutaneous Manifestations Associated With Mild-to-Moderate Seborrheic Dermatitis, and the Cutaneous Tolerability of the Cosmetic Product TRIDERM D.S. Crema Normalizzante.
Key Details
Gender
All
Age Range
0 Years - 3 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10
Completion Date
2027-02
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
TRIDERM D.S. Crema Normalizzante
TRIDERM D.S. Crema Normalizzante is a topical cosmetic product intended for use as a cosmetic adjunct in the presence of skin manifestations associated with seborrheic dermatitis. The product will be applied to the affected skin areas according to a two-phase regimen: an intensive phase consisting of two applications per day for 10 consecutive days, followed by a maintenance phase consisting of two applications per day on 3 days per week for the subsequent 2 weeks. After completion of the 24-day product-use period, no further product application will be performed during the 28-day follow-up period.
Locations (1)
Meyer Children's Hospital IRCCS
Florence, Tuscany, Italy