Estudo da eficácia de um Suplemento Alimentar na redução da Queda Capilar em Participantes Com eflúvio telógeno Associado ao Uso de análogos de GLP-1 Por Meio de avaliação clínica, percepção Subjetiva e Tricograma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Anagen-to-Telogen Hair Ratio (A:T)
研究概览
简要总结
A single-center, open-label clinical study to evaluate whether a dietary supplement can reduce hair loss in women with GLP-1-associated telogen effluvium. Participants will use the supplement for 120 days. Researchers will evaluate hair loss, hair density, and hair growth through clinical assessments, hair measurements (trichogram), and participant questionnaires.
详细描述
This prospective, single-center, open-label, interventional clinical study is designed to evaluate the efficacy and safety of a dietary supplement in women with telogen effluvium associated with the use of GLP-1 receptor agonists. A total of 48 female participants aged 20 to 60 years will be enrolled. Participants will receive the dietary supplement once daily for 120 days and will attend five study visits at baseline (Day 0) and after 30, 60, 90, and 120 days of supplementation.
The study is based on the hypothesis that nutritional supplementation may help improve hair growth cycle dynamics and reduce hair shedding in participants experiencing GLP-1-associated telogen effluvium. Efficacy will be evaluated using a combination of instrumental, clinical, and participant-reported assessments.
Instrumental evaluation will be performed through trichogram analysis at baseline, Day 60, and Day 120 to assess the distribution of hairs in the anagen and telogen phases and the anagen-to-telogen (A:T) ratio. Clinical assessments will be performed by a dermatologist at each visit using a Visual Analog Scale (VAS) to evaluate hair density, scalp coverage, and hair thinning. Participant-reported outcomes will be collected through structured questionnaires designed to assess perceived changes in hair shedding, hair growth, hair volume, hair strength, hair quality, and overall hair appearance during the supplementation period.
Safety and tolerability will be monitored throughout the study through the collection and evaluation of adverse events. Product adherence will be assessed through participant diaries and product accountability records. The study aims to generate clinical evidence regarding the effects of dietary supplementation on hair loss associated with GLP-1 receptor agonist use under real-world conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 20 to 60 years.
- •Dry, normal, combination, or oily scalp type.
- •Clinical diagnosis of telogen effluvium associated with the use of GLP-1 receptor agonists (semaglutide or tirzepatide), diagnosed by a dermatologist and confirmed by trichogram analysis.
- •Hair length of at least 3 cm.
- •Use of GLP-1 receptor agonists (semaglutide or tirzepatide) for at least 3 months prior to enrollment.
- •Intact skin in the study area (scalp).
- •Use of GLP-1 receptor agonists approved by ANVISA and commercially available in Brazil.
- •Under regular medical supervision during the study period.
- •Loss of at least 5% of initial body weight prior to enrollment.
- •Willingness to maintain the same hairstyle, haircut, and hair care habits throughout the study.
- •Willingness to comply with all study procedures and requirements.
- •Ability to provide written informed consent.
排除标准
- •Pregnancy, breastfeeding, postpartum period up to 6 months, or intention to become pregnant during the study.
- •Scalp conditions or skin marks that may interfere with study assessments.
- •Known allergy or hypersensitivity to any component of the investigational product or similar products.
- •Active scalp disorders that could interfere with study evaluations, including scarring alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate-to-severe seborrheic dermatitis, or eczema.
- •Use of nonsteroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizing agents, or immunosuppressants within 2 weeks before enrollment.
- •Ongoing radiotherapy or chemotherapy treatment.
- •Hair chemical procedures within 30 days prior to enrollment.
- •Recent use or dose adjustment of medications known to induce telogen effluvium.
- •Use of dietary supplements for hair loss within the previous 3 months.
- •Use of hair loss treatments or hair cycle modulators (e.g., minoxidil, finasteride, dutasteride, spironolactone) within the previous 3 months.
- •Hair transplantation within the previous 18 months.
- •Use of topical dermatological products for therapeutic or specific cosmetic purposes on the study area (scalp), such as hair tonics, topical minoxidil, medicated lotions, or acid-based treatments, within 48 hours prior to study initiation.
- •Initiation, discontinuation, or modification of hormone therapy within the previous 3 months.
- •Uncontrolled systemic diseases, including diabetes, lupus, thyroid disorders, anemia, or documented iron deficiency.
- •Bariatric surgery within the previous 12 months.
- •Hair loss associated with COVID-19 infection within the previous 6 months.
- •Hospitalization within the previous 6 months.
- •Major physical or psychological stressors within the previous 3 months.
- •Uncontrolled endocrine disorders.
- •History or evidence of alcohol or substance abuse.
- •Immunosuppression caused by medications or active diseases.
- •Excessive sun exposure or artificial tanning within 15 days before the baseline visit.
- •Participation in another clinical study.
- •Investigator site staff or family members directly involved in the study.
- •Any condition that, in the investigator's opinion, may compromise participant safety or study integrity.
结局指标
主要结局
Anagen-to-Telogen Hair Ratio (A:T)
时间窗: Baseline and Day 120
Change in the anagen-to-telogen hair ratio (A:T), assessed by trichogram analysis after 120 days of supplementation with a dietary supplement, compared with baseline (Day 0), in women with telogen effluvium associated with the use of GLP-1 receptor agonists.
次要结局
- Hair Thinning and Hair Density Assessment by Visual Analog Scale (VAS)(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Participant Self-Assessment of Hair Parameters Questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Incidence of Adverse Events(Day 30, Day 60, Day 90, and Day 120)
- Anagen-to-Telogen Hair Ratio (A:T) at Day 60(Baseline and Day 60)
- Change in hair thinning score assessed by Visual Analog Scale (VAS)(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in hair density score assessed by Visual Analog Scale (VAS)(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in perceived hair shedding assessed by a self-perception questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in perceived hair strength assessed by a self-perception questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in perceived hair volume assessed by a self-perception questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in perceived hair breakage assessed by a self-perception questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)
- Change in perceived overall hair appearance assessed by a self-perception questionnaire(Baseline, Day 30, Day 60, Day 90, and Day 120)