Effectiveness and Tolerability of VENEZE Peptide Factor Hair Serum for Pattern Hair Loss: A Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in hair density from baseline
研究概览
简要总结
This study aims to evaluate the effectiveness and tolerability of a peptide-based hair serum compared with topical minoxidil in patients with androgenetic alopecia. Participants will be randomly assigned, in a double-blind manner, to receive either the peptide hair serum or topical minoxidil. The primary objective is to assess improvement in hair growth over the study period, including changes in hair density and hair thickness. Secondary outcomes will include safety and tolerability assessments. The findings of this study may provide evidence supporting an alternative treatment option for patients with androgenetic alopecia.
详细描述
Androgenetic alopecia (AGA) is a common condition affecting both men and women and can significantly impact quality of life. Topical minoxidil is a widely used treatment; however, its effectiveness varies and it may cause local adverse effects in some patients. Peptide hair serums have emerged as a potential alternative, with proposed mechanisms including stimulation of hair follicle activity and promotion of hair growth.
This study aims to evaluate the efficacy and safety of a peptide-based hair serum compared with topical minoxidil in patients with androgenetic alopecia. The primary objective is to assess improvement in hair growth, including changes in hair density and hair thickness. Secondary objectives include evaluation of safety, tolerability, and patient-reported outcomes.
This is a randomized, double-blind, parallel-group study. Eligible participants with androgenetic alopecia will be randomly assigned to receive either the peptide-based hair serum or topical minoxidil. Treatments will be administered according to the study protocol over a defined study period.
Efficacy outcomes will include quantitative assessment of hair density and hair thickness. Safety will be evaluated through monitoring of adverse events and local tolerability.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥18 years.
- •Diagnosed with androgenetic alopecia (AGA): Norwood-Hamilton classification III-V in males or Ludwig classification I-II in females.
- •Able to read and write for completion of study questionnaires (e.g., Patient Global Assessment, Hair Growth Questionnaire).
- •Willing to comply with study procedures, including maintaining consistent hair color and hairstyle throughout the study.
- •Hair length in the non-balding area (vertex surrounding area) ≥2 cm at each visit.
- •Able to attend all scheduled visits during the 24-week study period.
排除标准
- •Presence of unstable or uncontrolled systemic diseases that may affect hair growth or loss within 6 months prior to screening (e.g., liver, renal, thyroid, cardiovascular, neurological diseases, diabetes, anemia).
- •History of malignancy within the past 5 years, except adequately treated basal cell carcinoma or squamous cell carcinoma.
- •Psychiatric disorders or other conditions that may affect participant safety or compliance.
- •Pregnant or breastfeeding women.
- •Hair and scalp-related exclusions:
- •Diffuse hair thinning involving the occipital area.
- •Scalp conditions or diseases affecting hair growth (e.g., tinea infection, non-AGA hair loss, psoriasis, uncontrolled seborrheic dermatitis).
- •History of hair transplantation at any time or hair extensions within 6 months prior to screening.
- •Use of cosmetic products for hair loss concealment within 2 weeks prior to screening.
- •Use of light/laser therapy on the scalp within 3 months prior to screening.
- •Use of supplements related to hair growth (e.g., zinc, biotin) within 3 months prior to screening.
- •Use of hair products containing active ingredients (e.g., caffeine, peptides) within 3 months prior to screening.
- •Hair procedures such as mesotherapy or stem cell injection within 3 months prior to screening.
- •Medication-related exclusions:
- •Known hypersensitivity to study-related products or ingredients.
- •Use of dutasteride within 12 months prior to screening.
- •Use of systemic cytotoxic agents.
- •Use of systemic glucocorticoids within 3 months prior to screening (except inhaled or topical corticosteroids not applied to the scalp).
- •Use within 6 months prior to screening of:
- •Minoxidil (topical or oral)
- •Finasteride (topical or oral)
- •Anti-androgenic drugs (e.g., spironolactone, cyproterone acetate, flutamide, bicalutamide)
- •Prostaglandin analogs applied to the scalp
- •Estrogen or progesterone topical preparations
- •Tamoxifen
- •Drugs associated with hypertrichosis (e.g., cyclosporine, phenytoin)
- •Drugs associated with hair loss (e.g., valproic acid)
- •Participation in another clinical trial within 1 month prior to screening or during this study.
研究组 & 干预措施
VENEZE Peptide factor hair serum
Participants in this arm will receive the VENEZE peptide factor hair serum applied topically to the scalp for 24 weeks.
干预措施: Veneze peptide hair serum (Other)
Topical 2% minoxidil solution
Participants in this arm will receive 2% minoxidil solution applied topically to the scalp for 24 weeks.
干预措施: Topical minoxidil (Drug)
结局指标
主要结局
Change in hair density from baseline
时间窗: 12 and 24 weeks
Change from baseline in hair count within approximately 1 cm² target area at the vertex scalp, measured using standardized macrophotographic techniques at Weeks 12 and 24.
次要结局
- Investigator Global Aesthetic Improvement Scale(12 and 24 weeks)
- Change in androgenetic alopecia severity(12 and 24 weeks)
- Patient Global Assessment of hair growth(12 and 24 weeks)
- Incidence of adverse events(24 weeks)
- Change in hair diameter and terminal hair count from baseline(12 and 24 weeks)
研究者
Chinmanat Lekhavat
Chief of Hair and Nail Center, Institute of Dermatology, Thailand
Institute of Dermatology, Thailand