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

What this Trial Is About

Researchers are studying the effect of glycomacropeptide, a milk-derived bioactive peptide, on children aged 2 to 12 years with mild atopic dermatitis. This skin condition causes itching, dryness, inflammation, and eczema, often affecting quality of life. The trial aims to see if applying glycomacropeptide cream reduces symptoms and changes skin bacteria, particularly Staphylococcus species, compared to a regular emollient cream. The study is randomized, double-blind, and involves pediatric participants with mild disease confirmed by specific criteria. Participants are randomly assigned to one of two groups: one uses an emollient cream containing 5% glycomacropeptide, and the other uses a similar cream without glycomacropeptide. Both creams are applied twice daily to affected skin areas for four weeks. The study includes a screening prick test to check for allergies to the cream components. Weekly clinic visits occur during the treatment for monitoring and collecting skin samples to analyze bacterial colonization. During the trial, children will have their atopic dermatitis severity measured using the SCORAD index and their itching and sleep quality assessed. Skin samples are taken at the start and end to study Staphylococcus colonization. Safety of the glycomacropeptide cream is monitored throughout. The total participation lasts four weeks with weekly visits for evaluation and data collection, including clinical exams and laboratory tests.

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