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 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.
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.
Factorial
Scalp Stimulating Serum
Other interventionParticipants 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.
Red Light Hair Growth Cap
DeviceParticipants 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.
Placebo scalp-stimulating serum
Other interventionParticipants 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.
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.
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.
Interfollicular Distance
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
Change in terminal-to-vellus hair ratio using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.
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.
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.
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.
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.
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K. Kay Durairaj, MD, FACS, A Medical Corporation
Lead sponsor
KeraFactor by SkinQRI
Collaborator
REVIAN, Inc.
Collaborator
