Effect of Glycomacropeptide on Clinical Manifestations of Atopic Dermatitis in Children: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the protective effect of glycomacropeptide on the clinical signs and symptoms of atopic dermatitis in children aged 2 to 12 years, and to determine if topical administration of glycomacropeptide is associated with a lower colonization by Staphylococcus species on the skin. The main questions that it aims to answer are: * Does glycomacropeptide reduce the signs and symptoms related to atopic dermatitis in the pediatric population? * Does glycomacropeptide modify the colonization of Staphylococcus species in atopic dermatitis lesions in the pediatric population? Researchers will compare an emollient cream containing glycomacropeptide with an emollient cream without glycomacropeptide to evaluate whether treatment with glycomacropeptide achieves a greater reduction in the clinical severity and pruritus of atopic dermatitis and a lower bacterial colonization compared with the exclusive use of emollients. Participants will: * Read and sign the informed consent * Undergo a prick test at the first visit to ensure no reaction to the treatment components * Receive the assigned treatment (glycomacropeptide cream or emollient cream), which must be applied twice daily only to atopic dermatitis lesions. * Visit the clinic once a week for 4 weeks for follow-up and SCORAD assessments, and for skin sample collection by stripping at first and last visit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 12
Healthy Volunteers: f
View:

• Children aged between 2 and 12 years.

• Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria.

• Mild atopic dermatitis with SCORAD \<25 points.

• Written informed consent signed by parents or legal guardian.

Locations
Other Locations
Mexico
Universidad Autónoma de Aguascalientes
RECRUITING
Aguascalientes
Contact Information
Primary
Eva M Salinas Miralles, PhD in medicine
maria.salinas@edu.uaa.mx
52 449-910-8424
Backup
Sandra J Pérez Carmona, MD
sandraperezcarmona@gmail.com
52 4499107400
Time Frame
Start Date: 2025-09-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Topical administration of an emollient cream formulated with glycomacropeptide
Topical administration of an emollient cream formulated with 5% glycomacropeptide, applied twice daily for 4 weeks, restricted to affected skin areas, in pediatric patients with atopic dermatitis
Active_comparator: Topical administration of the emollient cream formulated without glycomacropeptide
Topical administration of the emollient vehicle cream without glycomacropeptide, applied twice daily for 4 weeks to affected skin areas, in pediatric patients with atopic dermatitis
Related Therapeutic Areas
Sponsors
Leads: Universidad Autónoma de Aguascalientes

This content was sourced from clinicaltrials.gov