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Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

NCT07259343 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Atopic Dermatitis (AD)

Interventions

OTHER

glycomacropeptide

Topical application of an emollient cream formulated with 5% glycomacropeptide, applied twice daily for 4 weeks

OTHER

emollient cream

Topical administration of an emollient cream, applied twice daily for 4 weeks to affected skin areas

Sponsors & Collaborators

  • Universidad Autónoma de Aguascalientes

    lead OTHER

Principal Investigators

  • Eva M Salinas, PhD · Universidad Autónoma de Aguascalientes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2026-01-31
Completion
2026-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259343 on ClinicalTrials.gov