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 · NCT07259343 · Interventional (participants receive a specific treatment) · Lead sponsor: Universidad Autónoma de Aguascalientes
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Universidad Autónoma de Aguascalientes - Aguascalientes, Aguascalientes, Mexico