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Androgenic AlopeciaKDKR26NCT07810504

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

A study testing Scalp Stimulating Serum and Red Light Hair Growth Cap in people with Androgenic Alopecia and Female Pattern Hair Loss, run by K. Kay Durairaj, MD, FACS, A Medical Corporation at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 55 years, women only
What is being tested?
Scalp Stimulating Serum and Red Light Hair Growth Cap
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
17 Mar 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • K. Kay Durairaj, M.D., A Medical Corp.

    Pasadena, California, 91105

    Kalpna K Durairaj, MD, 6263167033, drkay@beautybydrkay.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Scalp Stimulating Serum, Red Light Hair Growth Cap, Placebo scalp-stimulating serum
Keywords
Red Light Therapy, Low-level Light Therapy, Hair Regrowth
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scalp Stimulating SerumOther

    Also called KeraFactor Scalp Stimulating Serum, KeraFactor Serum, KeraFactor

    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.

  • Red Light Hair Growth CapDevice

    Also called Revian Red Hair Growth System, Revian Red Cap, Revian Red Wireless Smart 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.

  • Placebo scalp-stimulating serumOther

    Also called Placebo scalp serum, Placebo solution

    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.

Study groups in NCT07810504
Study groupRoleWhat they receive
Scalp Stimulating Serum OnlyActive comparatorParticipants 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.
Receives: Other: Scalp Stimulating Serum
Placebo Solution + Revian Red CapActive comparatorParticipants 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.
Receives: Device: Red Light Hair Growth Cap; Other: Placebo scalp-stimulating serum
Scalp Stimulating Serum + Revian Red CapExperimentalParticipants 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.
Receives: Other: Scalp Stimulating Serum; Device: Red Light Hair Growth Cap
Placebo ComparatorPlacebo comparatorParticipants 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.
Receives: Other: Placebo scalp-stimulating serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 6 months

  2. 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.

    Measured: Baseline to 6 months

  3. Interfollicular Distance

    Change in interfollicular distance using AI HairMetrix analysis. Measurements will be compared from baseline to follow-up visits across treatment arms.

    Measured: Baseline to 6 months

  4. 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.

    Measured: Baseline to 6 months

Secondary outcomes (4)
  1. 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.

    Measured: Baseline to 6 months

  2. 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.

    Measured: Baseline to 6 months

  3. 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.

    Measured: Baseline to 6 months

  4. 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.

    Measured: Baseline through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start17 Mar 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07810504
Sponsor's protocol ID
KDKR26
Acronym
KDKR26
Status last verified
Sep 2026
First submitted
13 Jul 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Scalp Stimulating Serum and Red Light Hair Growth Cap in people with Androgenic Alopecia and Female Pattern Hair Loss, run by K. Kay Durairaj, MD, FACS, A Medical Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair Density (time frame: Baseline to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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