K. Kay Durairaj, MD, FACS, A Medical Corporation
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 p…
Inclusion Criteriaz: * 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 main…
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.
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.
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.
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