Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy (KDKR26)

Dual Modality Treatment of Androgenic Alopecia With KeraFactor® Solution and Revian® LED Light Therapy: A Randomized, Placebo Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Female Pattern Hair Loss; Androgenic Alopecia; Hair Loss
• Intervention / Treatment: Other: Scalp Stimulating Serum; Device: Red Light Hair Growth Cap; Other: Placebo scalp-stimulating serum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Recruiting
      • K. Kay Durairaj, M.D., A Medical Corp.
      • Contact: Kalpna K Durairaj, MD; Phone Number: 6263167033; Email: drkay@beautybydrkay.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: KeraFactor Scalp Stimulating Serum; KeraFactor Serum; KeraFactor
Active Comparator: 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.	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 Names: Revian Red Hair Growth System; Revian Red Cap; Revian Red Wireless Smart Cap Device; 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.; Other Names: Placebo solution; Placebo scalp serum
Experimental: 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.	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.; Other Names: KeraFactor Scalp Stimulating Serum; KeraFactor Serum; KeraFactor; 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 Names: Revian Red Hair Growth System; Revian Red Cap; Revian Red Wireless Smart Cap Device
Placebo Comparator: 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.	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.; Other Names: Placebo solution; Placebo scalp serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline through Week 24

Collaborators and Investigators

• Sponsor: K. Kay Durairaj, MD, FACS, A Medical Corporation
• Collaborators: KeraFactor by SkinQRI; REVIAN, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Hair Regrowth; Red Light Therapy; Low-level Light Therapy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia
• Other Study ID Numbers: KDKR26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No