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.
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.
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.
Parallel
glycomacropeptide
Other interventionTopical application of an emollient cream formulated with 5% glycomacropeptide, applied twice daily for 4 weeks
emollient cream
Other interventionTopical administration of an emollient cream, applied twice daily for 4 weeks to affected skin areas
Change in SCORAD index
Change in severity and extent of atopic dermatitis lesions assessed by the SCORAD (Scoring Atopic Dermatitis) index
Change in pruritus intensity
Change in pruritus intensity assessed by visual analogue scale where 0 in no itch and 10 is the worst imaginable itch
Change in sleep quality
Change in sleeplessness assessed by visual analogue scale where 0 in no sleeplessness and 10 is the worst imaginable sleeplessness
Change in staphylococcal skin colonization by Staphylococcus aureus and Staphylococcus epidermidis
Difference in the amount of Staphylococcus aureus and Staphylococcus epidermidis in lesional skin samples
Safety of glycomacropeptide topical application
Record and report of any adverse cutaneous reactions observed in patients receiving treatment
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