Actively Recruiting

Phase Not Applicable
Age: 2Years - 12Years
All Genders
NCT07259343

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

Led by Universidad Autónoma de Aguascalientes · Updated on 2025-12-02

20

Participants Needed

1

Research Sites

65 weeks

Total Duration

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AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 2 and 12 years
  • Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
  • Mild atopic dermatitis with SCORAD less than 25 points
  • Written informed consent signed by parents or legal guardian
Not Eligible

You will not qualify if you...

  • Age younger than 2 years or older than 12 years
  • Moderate to severe atopic dermatitis with SCORAD greater than 25 points
  • Presence of other dermatoses besides atopic dermatitis
  • History of hypersensitivity or anaphylaxis to any components of the vehicle cream
  • Allergy or hypersensitivity to glycomacropeptide
  • Inability to attend follow-up medical consultations or adhere to the treatment schedule
  • Any clinical reason determined by the investigator that makes the child unsuitable for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidad Autónoma de Aguascalientes

Aguascalientes, Aguascalientes, Mexico, 20100

Actively Recruiting

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Research Team

E

Eva M Salinas Miralles, PhD in medicine

CONTACT

S

Sandra J Pérez Carmona, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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