Effect of Glycomacropeptide on Clinical Manifestations of Atopic Dermatitis in Children: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in SCORAD index
研究概览
简要总结
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.
详细描述
Atopic dermatitis is a chronic and recurrent skin disease characterized by intense pruritus, dry skin, inflammation, and, in some cases, eczema. Although it can occur at any age, it is more common in childhood, with a global prevalence estimated between 5% and 20% in children, and approximately 7.3% in adults. Its impact on quality-of-life ranges from mild discomfort to significant sleep disturbances and limitations in daily activities.
The pathogenesis of atopic dermatitis is associated with structural and functional impairment of the epidermis, leading to inflammation, dysregulation of T helper cells (Th1/Th2), increased immunoglobulin E production, and mast cell hyperactivity, all of which exacerbate barrier abnormalities. The most common barrier defect is decreased production of filaggrin or other stratum corneum proteins, contributing to xerosis and increased susceptibility to infections. In addition, reduced production of antimicrobial peptides facilitates bacterial colonization.
Current treatment of atopic dermatitis relies on emollients, topical corticosteroids, and topical or systemic calcineurin inhibitors, depending on disease severity and persistence. However, prolonged use of these drugs can result in adverse effects such as burning, hypertrichosis, telangiectasias, skin atrophy, acne, folliculitis, contact dermatitis, nephrotoxicity, hepatotoxicity, seizures, and neoplasms. Therefore, there is a need for alternative treatments that can reduce quantity and time for drugs and promote patient recovery.
Glycomacropeptide is a 64-amino acid peptide derived from bovine casein during cheese production by chymosin or during milk digestion by pepsin. It is highly glycosylated, mainly at serine and threonine residues, with tetra-saccharides containing sialic acid as a key component of its bioactivity. Clinical studies have demonstrated the safety of oral glycomacropeptide in humans, and multiple biological activities have been described, including anti-inflammatory and anti-allergic effects in preclinical models of asthma, urticaria, food allergy, and atopic dermatitis.
About skin, glycomacropeptide has shown beneficial effects on keratinocytes, protecting them against apoptosis, inflammation, and oxidative stress, while promoting their migration and proliferation, processes that support skin repair in atopic conditions. Glycomacropeptide also inhibits mast cell and macrophage activation, key immune cells abundant in atopic dermatitis lesions that contribute to chronic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in SCORAD index
时间窗: From enrollment to the end of treatment at 4 weeks
Change in severity and extent of atopic dermatitis lesions assessed by the SCORAD (Scoring Atopic Dermatitis) index
Change in SCORAD index
时间窗: From enrollment to the end of treatment at 4 weeks
Change in severity and extent of atopic dermatitis lesions assessed by the SCORAD (Scoring Atopic Dermatitis) index
次要结局
- Safety of glycomacropeptide topical application(From enrollment to the end of treatment at 4 weeks)
- 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)
研究者
Eva María Salinas Miralles
Professor and Researcher, C
Universidad Autónoma de Aguascalientes