Emollient cream with a milk-derived peptide for children with mild atopic dermatitis
Effect of Glycomacropeptide on Clinical Manifestations of Atopic Dermatitis in Children: a Pilot Study
This trial will see if an emollient cream containing a milk peptide (glycomacropeptide) can reduce itch, skin signs, and Staphylococcus colonization in children aged 2–12 with mild atopic dermatitis compared with a regular emollient.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Universidad Autónoma de Aguascalientes Academic / other |
| Locations | 1 site (Aguascalientes, Aguascalientes) |
| Trial ID | NCT07259343 on ClinicalTrials.gov |
What this trial studies
Children aged 2–12 with mild atopic dermatitis (SCORAD <25) will be enrolled and receive either an emollient cream containing glycomacropeptide or the same emollient without the peptide, and outcomes will be compared between groups. Clinical severity scores and pruritus will be measured alongside skin cultures to quantify Staphylococcus colonization. The intervention is topical and used as an additive to standard emollient care, with parental consent required for participation. Exclusion criteria include moderate-to-severe AD, other dermatoses, known hypersensitivity to cream components, or inability to attend follow-up visits.
Who should consider this trial
Good fit: Children aged 2–12 years with a clinical diagnosis of atopic dermatitis by Hanifin and Rajka criteria, SCORAD under 25, and parental consent are the intended participants.
Not a fit: Children with moderate-to-severe atopic dermatitis (SCORAD >25), other active skin diseases, or known allergy to the cream components are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the peptide-containing emollient could reduce itch and visible eczema and lower bacterial colonization, offering a gentler topical option for children with mild AD.
How similar studies have performed: Topical use of glycomacropeptide for atopic dermatitis is relatively novel with limited prior clinical data, though related approaches using barrier-supporting or antimicrobial peptides have shown mixed or preliminary benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aguascalientes, Aguascalientes
- Universidad Autónoma de Aguascalientes — Aguascalientes, Aguascalientes, Mexico (Recruiting)
Study contacts
- Principal investigator: Eva M Salinas, PhD — Universidad Autónoma de Aguascalientes
- Study coordinator: Eva M Salinas Miralles, PhD in medicine
- Email: maria.salinas@edu.uaa.mx
- Phone: 52 449-910-8424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.