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

Recruiting now · Not applicable

Conditions studied: Atopic Dermatitis (AD)

In brief

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.

Key facts

Study ID

NCT07259343

Run by

Universidad Autónoma de Aguascalientes

People needed

20

Starts

2025-09-26

Expected to finish

2026-12-31

Last updated by the study team

2025-12-02

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Age younger than 2 years or older than 12 years.
• Moderate to severe atopic dermatitis (SCORAD >25 points).
• Presence of other dermatoses in addition to atopic dermatitis.
• Background of hypersensitivity or anaphylaxis to any components of the vehicle cream.
• Allergy or hypersensitivity to glycomacropeptide.
• Inability to attend follow-up medical consultations or to adhere to the treatment schedule.
• Any clinical reason determined by the clinical investigator that makes the child unsuitable for the study.

Where it is running

• Universidad Autónoma de Aguascalientes — Aguascalientes, Aguascalientes, Mexico (enrolling)

Full record on ClinicalTrials.gov

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