Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy: A Randomized, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hair Density
研究概览
简要总结
This single-center, prospective, randomized, placebo-controlled interventional study will evaluate the safety and efficacy of KeraFactor scalp-stimulating solution and the Revian Red wireless smart cap, alone and in combination, for the treatment of female androgenic alopecia. Forty female subjects aged 35 to 55 with clinically diagnosed androgenic alopecia will be randomized into four treatment arms and followed for 24 weeks. The primary objective is to determine whether combination therapy produces greater improvement in hair growth from baseline to 6 months compared with solution alone, device alone, or placebo. Secondary outcomes include changes in hair density, hair fiber diameter, interfollicular distance, terminal-to-vellus hair ratio, patient satisfaction, and safety/tolerability.
详细描述
Female pattern hair loss is a common progressive condition characterized by follicular miniaturization, reduced hair density, and altered anagen-to-telogen ratios. Available treatments may provide partial or inconsistent results, creating a need for additional non-surgical, low-maintenance therapeutic approaches.
This study is designed to evaluate a dual-modality treatment approach using KeraFactor scalp-stimulating solution and the Revian Red wireless smart cap. Participants will be randomized in a 1:1:1:1 allocation to one of four groups: scalp-stimulating solution alone, placebo solution plus Revian Red cap, scalp-stimulating solution plus Revian Red cap, or placebo solution alone. The active and placebo solutions will be double-blinded, while device assignment will be open-label. Outcome assessors will remain blinded to treatment assignment to the extent feasible.
Screening will include medical history, scalp examination, and laboratory testing, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total testosterone, estradiol, and FSH. Menopausal status will be used for stratification during randomization. Eligible subjects will complete in-office assessments at baseline, Week 12, and Week 24.
Study assessments will include standardized clinical photography, high-resolution DSLR photography, AI HairMetrix analysis, physician and patient Global Aesthetic Improvement Scale ratings, Ludwig Scale assessment, patient satisfaction questionnaires, adherence review, and adverse event monitoring. Quantitative endpoints will include hair density, hair fiber diameter, follicular unit composition, average hairs per follicular unit, interfollicular distance, and terminal-to-vellus hair ratio.
Subjects who complete the 24-week study will receive one Revian Red cap device and a six-month supply of KeraFactor serum after completion of the controlled study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The scalp-stimulating solution and placebo solution will be double-blinded. Active and placebo solutions will be identical in appearance and packaging and labeled with coded identifiers. Device assignment will be open-label, as participants will know whether they are assigned to use the Revian Red Cap. Outcome assessors performing photography, HairMetrix capture, hair counts/metrics review, and global scale assessments will remain blinded to treatment assignments to the extent feasible.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 35 to 55 years, inclusive.
- •Clinically diagnosed with androgenic alopecia.
- •Fitzpatrick Skin Types I-VI.
- •Willingness to undergo baseline laboratory screening, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total testosterone, estradiol (E2), and FSH, to confirm eligibility and stratification status.
- •Generally healthy individuals with no significant dermatological conditions affecting the scalp, such as eczema, psoriasis, or folliculitis, that could interfere with treatment assessment.
- •Willingness to maintain a consistent hair care routine and refrain from new hair treatments, supplements, or grooming practices that could confound study results.
- •Willingness and ability to provide recent laboratory results to establish baseline metabolic parameters.
- •Participants must have a smartphone or tablet that operates on iOS version 11.0 or higher and/or Android 9.0 or higher, access to the Apple App Store or Google Play to download the REVIAN app, and internet or wireless network connectivity.
- •Commitment to avoid hair dryer use for at least 48 hours before and after each office visit.
- •Commitment to avoid hair extensions for at least 6 months prior to and throughout the study duration.
- •Ability and willingness to adhere to the study protocol, including scheduled visits and assessments.
- •Willingness to allow trichoscopic and photographic documentation of the scalp and hair.
- •Ability and willingness to provide written informed consent after being fully informed about the study's nature, purpose, procedures, potential risks, and benefits.
排除标准
- •Presence of autoimmune or pathologic causes of hair loss, such as alopecia areata or lichen planus.
- •Active scalp disorders or infections, such as eczema, psoriasis, seborrheic dermatitis, or folliculitis.
- •Clinically significant abnormalities in baseline screening labs, including CBC, TSH, iron/TIBC, 25-hydroxyvitamin D, ferritin, free testosterone, total testosterone, E2, and FSH, that fall outside satisfactory ranges for hair growth or indicate an underlying medical pathology, such as iron deficiency anemia or thyroid dysfunction.
- •History of hypersensitivity to any components of KeraFactor scalp-stimulating solution.
- •Presence of a medical condition that makes the skin sensitive to sun or light, or use of photosensitizing medications, shampoos, lotions, or other therapies that sensitize the skin to light.
- •Medical conditions or medications known to significantly affect hair growth, including uncontrolled thyroid disorders, anemia, cancer, chemotherapy, spironolactone, 5-alpha-reductase inhibitors, or cyproterone.
- •Active use of GLP-1 receptor agonists, such as Ozempic, Wegovy, Mounjaro, Zepbound, or similar medications.
- •Active use of topical treatments for hair regrowth, such as minoxidil or finasteride.
- •Pregnant, breastfeeding, or planning to become pregnant during the study.
- •Unrealistic expectations or psychological conditions that may impact study compliance or satisfaction.
- •Continual use of red-light or low-level laser therapy outside of study requirements.
- •Recent initiation of topical hair regrowth treatments, such as minoxidil or finasteride.
- •Continual use of minoxidil, finasteride, or other hair regrowth treatments.
- •Any active cancer or cancer diagnosis.
- •Active smoking habit.
- •History of hair transplant procedures.
- •Significant scalp scarring or structural anomalies in treatment zones.
- •Recent major surgeries or medical interventions within the last 3 months.
- •History of prolonged or repeated mechanical tension on the hair or scalp, such as tight hairstyles contributing to traction alopecia.
研究组 & 干预措施
Scalp Stimulating Serum Only
Participants assigned to this arm will apply KeraFactor scalp-stimulating solution directly to the scalp once daily and massage it in gently. Participants in this arm will not use the Revian Red Cap during the controlled study period.
干预措施: Scalp Stimulating Serum (Other)
Placebo Solution + Revian Red Cap
Participants assigned to this arm will apply placebo scalp-stimulating solution directly to the scalp once daily and massage it in gently. Participants will also use the Revian Red Cap once daily for 10 minutes according to device instructions.
干预措施: Red Light Hair Growth Cap (Device)
Placebo Solution + Revian Red Cap
Participants assigned to this arm will apply placebo scalp-stimulating solution directly to the scalp once daily and massage it in gently. Participants will also use the Revian Red Cap once daily for 10 minutes according to device instructions.
干预措施: Placebo scalp-stimulating serum (Other)
Scalp Stimulating Serum + Revian Red Cap
Participants assigned to this arm will apply KeraFactor scalp-stimulating solution directly to the scalp once daily and massage it in gently. Immediately after application, participants will use the Revian Red Cap once daily for 10 minutes according to device instructions.
干预措施: Scalp Stimulating Serum (Other)
Scalp Stimulating Serum + Revian Red Cap
Participants assigned to this arm will apply KeraFactor scalp-stimulating solution directly to the scalp once daily and massage it in gently. Immediately after application, participants will use the Revian Red Cap once daily for 10 minutes according to device instructions.
干预措施: Red Light Hair Growth Cap (Device)
Placebo Comparator
Participants assigned to this arm will apply placebo scalp-stimulating solution directly to the scalp once daily and massage it in gently. Participants in this arm will not use the Revian Red Cap during the controlled study period.
干预措施: Placebo scalp-stimulating serum (Other)
结局指标
主要结局
Hair Density
时间窗: Baseline to 6 months
Change in hair density, measured as hairs per cm², using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
Hair Fiber Diameter
时间窗: Baseline to 6 months
Change in average hair fiber diameter, measured in micrometers, using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
Interfollicular Distance
时间窗: Baseline to 6 months
Change in interfollicular distance using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
Terminal-to-Vellus Hair Ratio
时间窗: Baseline to 6 months
Change in terminal-to-vellus hair ratio using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
次要结局
- Ludwig-Savin Scale for Women(Baseline to 6 months)
- Hair Life Quality Index(Baseline to 6 months)
- Hair-Q: Satisfaction with Hair(Baseline to 6 months)
- Incidence and Severity of Adverse Events(Baseline through Week 24)
研究者
Kalpna Kay Durairaj, MD, FACS
Principal Investigator
K. Kay Durairaj, MD, FACS, A Medical Corporation