NCT07835646尚未招募不适用
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of an Oral Dietary Supplement for Occasional Telogen Effluvium in Adult Men and Women.
Lacer S.A.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in the number of shed hairs at 3 Months
研究概览
简要总结
The goal of this study is to learn if dietary supplement works to help with improving hair condition in subjects with occasional hair loss. It will also learn about its safety. The main question it aims to answer is:
• Does the dietary supplement reduce the number of hair lost by participants? Researchers will compare dietary supplement to a placebo (a look-alike substance that contains no drug) to see if it works to reduce hair loss.
Participants will:
- Take dietary supplement or a placebo every day for 3 months
- Visit the clinic every month for evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 70 years.
- •Self-perceived occasional telogen effluvium, with a count of 100 or more shed hairs in the standardized wash and combing test, confirmed at the screening visit (Visit 0), of recent onset (less than 6 months) and attributable to factors such as stress, nutritional deficiency, pollution, or seasonality.
- •Good general health, in the investigator's judgment, with no relevant uncontrolled systemic disease.
- •Availability and willingness to attend the three study visits and comply with study procedures over a 90-day period.
- •Agreement to receive study-related communications electronically (email and/or SMS), where expressly authorized.
- •Ability to understand the study and provide written informed consent.
排除标准
- •Refusal to provide informed consent to participate in the study.
- •Inability to understand the study language.
- •Pregnancy or breastfeeding.
- •Established androgenetic alopecia (Hamilton-Norwood classification or other pattern hair loss disorders) or other forms of alopecia (alopecia areata, scarring alopecia, trichotillomania, or others) diagnosed or suspected by the investigator.
- •Use of specific pharmacological or cosmetic treatments for hair loss (minoxidil, finasteride, topical or systemic corticosteroids, other dietary supplements, or hair lotions) within the 3 months prior to enrollment.
- •Uncontrolled endocrine disease (e.g., thyroid disorders), diagnosed severe nutritional deficiency, untreated anemia, or a recent history (< 6 months) of severe febrile illness, major surgery, or childbirth.
- •Active scalp dermatological conditions (psoriasis, moderate-to-severe seborrheic dermatitis, fungal or bacterial infections) that may interfere with clinical assessment or instrumental evaluation techniques.
- •Any disease, treatment, or characteristic that, in the investigator's opinion, may preclude participation due to unnecessary risk or interference with the study and/or interpretation of the results, particularly:
- •Use of aspirin or related compounds, antibiotics, anti-inflammatory drugs, corticosteroids, antidepressants, antihistamines, or immunosuppressive treatments.
- •Ongoing allergen desensitization therapy (allergy immunotherapy).
- •Presence of dermatological abnormalities in the study area, such as irritation, erythema, scars, pigmentation disorders, numerous freckles, or nevi.
- •History of intolerance or allergy to medications or other substances that may pose an unjustified risk.
- •Use of a nutricosmetic supplement within the 3 months prior to study initiation or during the entire study period.
- •History of intolerance or allergy to cosmetic products of the same type as the investigational product.
- •Receipt of a vaccination within the previous month or planned vaccination during the study period.
- •Surgical intervention in the study area within the month prior to study initiation or during the study.
- •Undergoing aesthetic procedures that may affect the scalp during the study, such as oxidative root hair coloring, perming, Japanese straightening, keratin straightening, or full hair bleaching (color rinses, temporary dyes, highlights, light hairstyling, and salon styling procedures are permitted).
- •Combing, washing, or dyeing the hair within the 48 hours preceding a study visit.
- •Simultaneous participation in other studies related to the same therapeutic or application area.
- •Modification of cosmetic habits in the study area within the 15 days prior to study initiation.
- •Exposure to intense sunlight or ultraviolet (UV) radiation within the month prior to study enrollment, or anticipated exposure during the study period.
研究组 & 干预措施
Dietary supplement capsule
Experimental
干预措施: Dietary supplement for hair loss (Dietary Supplement)
Placebo capsule
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in the number of shed hairs at 3 Months
时间窗: From enrollment to the end of treatment at 3 months
Hair loss will be evaluated by wash and combing test
次要结局
未报告次要终点
研究者
研究点 (1)
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