An interventional study of Scalp Stimulating Serum and Red Light Hair Growth Cap in Androgenic Alopecia, Female Pattern Hair Loss and Hair Loss, sponsored by K. Kay Durairaj, MD, FACS, A Medical Corporation. Recruiting at 1 site in United States. Open to female participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by K. Kay Durairaj, MD, FACS, A Medical Corporation · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Other: Scalp Stimulating Serum
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.
Device: Red Light Hair Growth Cap · Other: Placebo scalp-stimulating serum
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.
Other: Scalp Stimulating Serum · Device: Red Light Hair Growth Cap
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.
Other: Placebo scalp-stimulating serum
Participants assigned to receive the active scalp-stimulating serum will apply one full dropper directly to the scalp once daily and massage it in gently. The product should not be rinsed off. In the combination treatment arm, the serum will be applied immediately before use of the Revian Red Cap.
Also known as: KeraFactor Scalp Stimulating Serum, KeraFactor Serum, KeraFactor
Participants assigned to use the Revian Red Cap will use the device once daily for 10 minutes at a convenient time. The device should be used indoors or in a cool, dry area and only on dry or towel-dried hair. Study staff will assist with unboxing, app registration, and device training at the baseline visit. Device use will be logged through the Revian app.
Also known as: Revian Red Hair Growth System, Revian Red Cap, Revian Red Wireless Smart Cap Device
Participants assigned to receive placebo serum will apply one full dropper directly to the scalp once daily and massage it in gently. The placebo product should not be rinsed off. The placebo serum will be identical in appearance and packaging to the active serum and labeled with coded identifiers to maintain blinding.
Also known as: Placebo scalp serum, Placebo solution
Hair Density
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.
Time frame: Baseline to 6 months
Hair Fiber Diameter
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.
Time frame: Baseline to 6 months
Interfollicular Distance
Change in interfollicular distance using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
Time frame: Baseline to 6 months
Terminal-to-Vellus Hair Ratio
Change in terminal-to-vellus hair ratio using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
Time frame: Baseline to 6 months
Ludwig-Savin Scale for Women
The participant will be rated at each live assessment. The photonumeric scale classifies female-pattern hair loss into stages (I-1, I-2, I-3, I-4, II-1, II-2, and frontal) of increasing crown balding, in addition to a special subcategory to detect frontal anterior recession.
Time frame: Baseline to 6 months
Hair Life Quality Index
A 10-question skin health index modified to asses how severely hair and scalp problems affect a a patient's life over the previous week. Responses to each question may vary between the following choices: very much, a lot, a little, not at all, not relevant.
Time frame: Baseline to 6 months
Hair-Q: Satisfaction with Hair
A 14-item patient-reported outcome measure used to evaluate patient satisfaction with hair appearance and treatments. Responses to each question may vary between the following choices: 1-very dissatisfied, 2-somewhat dissatisfied, 3-somewhat satisfied, 4-very satisfied.
Time frame: Baseline to 6 months
Incidence and Severity of Adverse Events
Safety and tolerability will be assessed by monitoring the incidence, severity, and type of adverse events throughout the study. Adverse events will be categorized as treatment-related or treatment-unrelated and classified according to CTCAE criteria, with attention to local skin reactions, systemic reactions, and neurological symptoms.
Time frame: Baseline through Week 24
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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