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

NCT07810504 | Recruiting FDA Device

• 1 other identifier: KDKR26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Androgenic Alopecia; Female Pattern Hair Loss; Hair Loss

Keywords

Red Light Therapy; Low-level Light Therapy; Hair Regrowth

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Ludwig-Savin Scale for Women

  Baseline to 6 months

• Hair Life Quality Index

  Baseline to 6 months

• Hair-Q: Satisfaction with Hair

  Baseline to 6 months

• Incidence and Severity of Adverse Events

  Baseline through Week 24

Study Arms (4)

Scalp Stimulating Serum Only

ACTIVE COMPARATOR

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

Placebo Solution + Revian Red Cap

ACTIVE COMPARATOR

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

Scalp Stimulating Serum + Revian Red Cap

EXPERIMENTAL

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

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

Interventions

Scalp Stimulating Serum OTHER

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

Scalp Stimulating Serum + Revian Red Cap; Scalp Stimulating Serum Only

Red Light Hair Growth Cap DEVICE

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

Placebo Solution + Revian Red Cap; Scalp Stimulating Serum + Revian Red Cap

Placebo scalp-stimulating serum OTHER

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

Placebo Comparator; Placebo Solution + Revian Red Cap

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• K. Kay Durairaj, MD, FACS, A Medical Corporation: lead
• KeraFactor by SkinQRI: collaborator
• REVIAN, Inc.: collaborator

Study Sites (1)

K. Kay Durairaj, M.D., A Medical Corp.

Pasadena, California, 91105, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The scalp-stimulating solution and placebo solution will be double-blinded. Active and placebo solutions will be identical in appearance and packaging and labeled with coded identifiers. Device assignment will be open-label, as participants will know whether they are assigned to use the Revian Red Cap. Outcome assessors performing photography, HairMetrix capture, hair counts/metrics review, and global scale assessments will remain blinded to treatment assignments to the extent feasible.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1:1:1 allocation to one of four treatment arms evaluating two intervention variables: scalp-stimulating solution versus placebo solution, and Revian Red Cap use versus no cap use. The four arms include scalp-stimulating solution alone, placebo solution plus Revian Red Cap, scalp-stimulating solution plus Revian Red Cap, and placebo solution alone.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: September 9, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

US (1)