Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and … (NCT07259343) | Clinical Trial Compass
RecruitingNot Applicable
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
Mexico20 participantsStarted 2025-09-26
Plain-language summary
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 participate
Age range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in SCORAD index
Timeframe: From enrollment to the end of treatment at 4 weeks