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

NCT07259343 | Recruiting

• 2 other identifiers: COB-UAA/09/2024PIBB26-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis (AD)

Keywords

glycomacropeptide; eczema; priritus; Staphylococcus

Outcome Measures

Primary Outcomes (1)

• Change in SCORAD index

  Change in severity and extent of atopic dermatitis lesions assessed by the SCORAD (Scoring Atopic Dermatitis) index

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (4)

• Change in pruritus intensity

  From enrollment to the end of treatment at 4 weeks

• Change in sleep quality

  From enrollment to the end of treatment at 4 weeks.

• Change in staphylococcal skin colonization by Staphylococcus aureus and Staphylococcus epidermidis

  From enrollment to the end of treatment at 4 weeks

• Safety of glycomacropeptide topical application

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Topical administration of an emollient cream formulated with glycomacropeptide

EXPERIMENTAL

Topical administration of an emollient cream formulated with 5% glycomacropeptide, applied twice daily for 4 weeks, restricted to affected skin areas, in pediatric patients with atopic dermatitis

Other: glycomacropeptide

Topical administration of the emollient cream formulated without glycomacropeptide

ACTIVE COMPARATOR

Topical administration of the emollient vehicle cream without glycomacropeptide, applied twice daily for 4 weeks to affected skin areas, in pediatric patients with atopic dermatitis

Other: emollient cream

Interventions

glycomacropeptide OTHER

Topical application of an emollient cream formulated with 5% glycomacropeptide, applied twice daily for 4 weeks

Topical administration of an emollient cream formulated with glycomacropeptide

emollient cream OTHER

Topical administration of an emollient cream, applied twice daily for 4 weeks to affected skin areas

Topical administration of the emollient cream formulated without glycomacropeptide

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autónoma de Aguascalientes: lead

Study Sites (1)

Universidad Autónoma de Aguascalientes

Aguascalientes, Aguascalientes, 20100, Mexico

RECRUITING

Related Publications (25)

• Ogai K, Nagase S, Mukai K, Iuchi T, Mori Y, Matsue M, Sugitani K, Sugama J, Okamoto S. A Comparison of Techniques for Collecting Skin Microbiome Samples: Swabbing Versus Tape-Stripping. Front Microbiol. 2018 Oct 2;9:2362. doi: 10.3389/fmicb.2018.02362. eCollection 2018.

  PMID: 30333815 BACKGROUND

• Ogai K, Shibata K, Takahashi N, Ogura K, Okamoto S, Sugama J. Amplicon-based skin microbiome profiles collected by tape stripping with different adhesive film dressings: a comparative study. BMC Microbiol. 2021 Feb 18;21(1):54. doi: 10.1186/s12866-021-02122-4.

  PMID: 33602131 BACKGROUND

• Oppenheimer J, Nelson HS. Skin testing: a survey of allergists. Ann Allergy Asthma Immunol. 2006 Jan;96(1):19-23. doi: 10.1016/S1081-1206(10)61034-4.

  PMID: 16440527 BACKGROUND

• Nelson HS, Knoetzer J, Bucher B. Effect of distance between sites and region of the body on results of skin prick tests. J Allergy Clin Immunol. 1996 Feb;97(2):596-601. doi: 10.1016/s0091-6749(96)70304-4.

  PMID: 8621844 BACKGROUND

• Manguy J, Shields DC. Implications of kappa-casein evolutionary diversity for the self-assembly and aggregation of casein micelles. R Soc Open Sci. 2019 Oct 16;6(10):190939. doi: 10.1098/rsos.190939. eCollection 2019 Oct.

  PMID: 31824707 BACKGROUND

• Zhou H, Tan X, Chen G, Liu X, Feng A, Liu Z, Liu W. Extracellular Vesicles of Commensal Skin Microbiota Alleviate Cutaneous Inflammation in Atopic Dermatitis Mouse Model by Re-Establishing Skin Homeostasis. J Invest Dermatol. 2025 Feb;145(2):312-322.e9. doi: 10.1016/j.jid.2023.02.023. Epub 2023 Mar 11.

  PMID: 36907322 BACKGROUND

• Koh LF, Ong RY, Common JE. Skin microbiome of atopic dermatitis. Allergol Int. 2022 Jan;71(1):31-39. doi: 10.1016/j.alit.2021.11.001. Epub 2021 Nov 24.

  PMID: 34838450 BACKGROUND

• Jimenez M, Cervantes-Garcia D, Munoz YH, Garcia A, Haro LM Jr, Salinas E. Novel Mechanisms Underlying the Therapeutic Effect of Glycomacropeptide on Allergy: Change in Gut Microbiota, Upregulation of TGF-beta, and Inhibition of Mast Cells. Int Arch Allergy Immunol. 2016;171(3-4):217-226. doi: 10.1159/000453035. Epub 2017 Jan 4.

  PMID: 28049206 BACKGROUND

• Gallegos-Alcala P, Jimenez M, Cervantes-Garcia D, Cordova-Davalos LE, Gonzalez-Curiel I, Salinas E. Glycomacropeptide Protects against Inflammation and Oxidative Stress, and Promotes Wound Healing in an Atopic Dermatitis Model of Human Keratinocytes. Foods. 2023 May 9;12(10):1932. doi: 10.3390/foods12101932.

  PMID: 37238750 BACKGROUND

• Jimenez M, Munoz FC, Cervantes-Garcia D, Cervantes MM, Hernandez-Mercado A, Barron-Garcia B, Moreno Hernandez-Duque JL, Rodriguez-Carlos A, Rivas-Santiago B, Salinas E. Protective Effect of Glycomacropeptide on the Atopic Dermatitis-Like Dysfunctional Skin Barrier in Rats. J Med Food. 2020 Nov;23(11):1216-1224. doi: 10.1089/jmf.2019.0247. Epub 2020 Mar 9.

  PMID: 32155356 BACKGROUND

• Roldan NR, Jimenez M, Cervantes-Garcia D, Marin E, Salinas E. Glycomacropeptide administration attenuates airway inflammation and remodeling associated to allergic asthma in rat. Inflamm Res. 2016 Apr;65(4):273-83. doi: 10.1007/s00011-015-0913-y. Epub 2016 Jan 11.

  PMID: 26755379 BACKGROUND

• Reyes-Pavon D, Cervantes-Garcia D, Bermudez-Humaran LG, Cordova-Davalos LE, Quintanar-Stephano A, Jimenez M, Salinas E. Protective Effect of Glycomacropeptide on Food Allergy with Gastrointestinal Manifestations in a Rat Model through Down-Regulation of Type 2 Immune Response. Nutrients. 2020 Sep 25;12(10):2942. doi: 10.3390/nu12102942.

  PMID: 32992996 BACKGROUND

• Munoz FC, Cervantes MM, Cervantes-Garcia D, Jimenez M, Ventura-Juarez J, Salinas E. Glycomacropeptide Attenuates Inflammation, Pruritus, and Th2 Response Associated with Atopic Dermatitis Induced by 2,4-Dinitrochlorobenzene in Rat. J Immunol Res. 2017;2017:6935402. doi: 10.1155/2017/6935402. Epub 2017 Feb 7.

  PMID: 28265582 BACKGROUND

• Jimenez M, Chavez NA, Salinas E. Pretreatment with glycomacropeptide reduces allergen sensitization, alleviates immediate cutaneous hypersensitivity and protects from anaphylaxis. Clin Exp Immunol. 2012 Oct;170(1):18-27. doi: 10.1111/j.1365-2249.2012.04631.x.

  PMID: 22943197 BACKGROUND

• Wernlund PG, Hvas CL, Dahlerup JF, Bahl MI, Licht TR, Knudsen KEB, Agnholt JS. Casein glycomacropeptide is well tolerated in healthy adults and changes neither high-sensitive C-reactive protein, gut microbiota nor faecal butyrate: a restricted randomised trial. Br J Nutr. 2021 Jun 28;125(12):1374-1385. doi: 10.1017/S0007114520003736. Epub 2020 Sep 24.

  PMID: 32967742 BACKGROUND

• Hvas CL, Dige A, Bendix M, Wernlund PG, Christensen LA, Dahlerup JF, Agnholt J. Casein glycomacropeptide for active distal ulcerative colitis: a randomized pilot study. Eur J Clin Invest. 2016 Jun;46(6):555-63. doi: 10.1111/eci.12634.

  PMID: 27090817 BACKGROUND

• Ney DM, Etzel MR. Designing medical foods for inherited metabolic disorders: why intact protein is superior to amino acids. Curr Opin Biotechnol. 2017 Apr;44:39-45. doi: 10.1016/j.copbio.2016.10.009. Epub 2016 Nov 16.

  PMID: 27835797 BACKGROUND

• Saito T, Itoh T. Variations and distributions of O-glycosidically linked sugar chains in bovine kappa-casein. J Dairy Sci. 1992 Jul;75(7):1768-74. doi: 10.3168/jds.S0022-0302(92)77936-3.

  PMID: 1500573 BACKGROUND

• Manthripragada AD, Pinheiro SP, MaCurdy TE, Saneinejad S, Worrall CM, Kelman JA, Graham DJ. Off-label topical calcineurin inhibitor use in children. Pediatrics. 2013 Nov;132(5):e1327-32. doi: 10.1542/peds.2013-0931. Epub 2013 Oct 14.

  PMID: 24127469 BACKGROUND

• Ogonowska P, Gilaberte Y, Baranska-Rybak W, Nakonieczna J. Colonization With Staphylococcus aureus in Atopic Dermatitis Patients: Attempts to Reveal the Unknown. Front Microbiol. 2021 Jan 11;11:567090. doi: 10.3389/fmicb.2020.567090. eCollection 2020.

  PMID: 33505363 BACKGROUND

• Di Domenico EG, Cavallo I, Bordignon V, Prignano G, Sperduti I, Gurtner A, Trento E, Toma L, Pimpinelli F, Capitanio B, Ensoli F. Inflammatory cytokines and biofilm production sustain Staphylococcus aureus outgrowth and persistence: a pivotal interplay in the pathogenesis of Atopic Dermatitis. Sci Rep. 2018 Jun 28;8(1):9573. doi: 10.1038/s41598-018-27421-1.

  PMID: 29955077 BACKGROUND

• Gallegos-Alcala P, Jimenez M, Cervantes-Garcia D, Salinas E. The Keratinocyte as a Crucial Cell in the Predisposition, Onset, Progression, Therapy and Study of the Atopic Dermatitis. Int J Mol Sci. 2021 Oct 1;22(19):10661. doi: 10.3390/ijms221910661.

  PMID: 34639001 BACKGROUND

• Al-Khenaizan S. Practical tip: Precooling topical calcineurin inhibitors tube; reduces burning sensation. Dermatol Online J. 2010 Apr 15;16(4):16.

  PMID: 20409423 BACKGROUND

• Egeberg A, Schwarz P, Harslof T, Andersen YMF, Pottegard A, Hallas J, Thyssen JP. Association of Potent and Very Potent Topical Corticosteroids and the Risk of Osteoporosis and Major Osteoporotic Fractures. JAMA Dermatol. 2021 Mar 1;157(3):275-282. doi: 10.1001/jamadermatol.2020.4968.

  PMID: 33471030 BACKGROUND

• 1. Arenas R. Dermatología, atlas, diagnóstico y tratamiento. 7ma ed. México, Ciudad de México: Mc Graw Hill; 2019.

  BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

caseinomacropeptide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eva M Salinas, PhD

  Universidad Autónoma de Aguascalientes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva M Salinas Miralles, PhD in medicine

CONTACT

52 449-910-8424; maria.salinas@edu.uaa.mx

Sandra J Pérez Carmona, MD

CONTACT

52 4499107400; sandraperezcarmona@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher, C

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 2, 2025
• Study Start: September 26, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication of primary results and for up to 5 years.
• Access Criteria: Upon reasonable request from qualified researchers for academic purposes

Locations

ME (1)