NCT07810504 · K. Kay Durairaj, MD, FACS, A Medical Corporation
Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy
(KDKR26)
What this study is about
This single-center, forward-looking, randomly assigned, compared against an inactive treatment interventional study will evaluate the safety and effectiveness of KeraFactor scalp-stimulating solution and the Revian Red wireless smart cap, alone and in combination, for the treatment of female androgenic alopecia.
View original scientific description
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.
Interventions
OTHER
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.
DEVICE
Red Light Hair Growth 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.
OTHER
Placebo scalp-stimulating serum
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.
Primary outcome measures
Hair Density
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Pasadena, California
Collaborators
KeraFactor by SkinQRI, REVIAN, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations