Recruiting

KeraFactor & Revian Red

Sponsor:

K. Kay Durairaj, MD, FACS, A Medical Corporation

Code:

NCT07810504

Conditions

Androgenic Alopecia

Female Pattern Hair Loss

Hair Loss

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

Interventions

Scalp Stimulating Serum

Red Light Hair Growth Cap

Placebo scalp-stimulating serum

Study Details

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

Study ID

NCT07810504

Start date

Mar 17, 2026

Status verified date

Sep, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

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.

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 measure

  • Hair Density [ Time Frame: Baseline to 6 months ]
  • Hair Fiber Diameter [ Time Frame: Baseline to 6 months ]
  • Interfollicular Distance [ Time Frame: Baseline to 6 months ]
  • Terminal-to-Vellus Hair Ratio [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Locations

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

Recruiting

Pasadena, California, United States, 91105

Contacts

Kalpna K Durairaj, MD

6263167033drkay@beautybydrkay.com

More Information

Sponsor

K. Kay Durairaj, MD, FACS, A Medical Corporation

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by K. Kay Durairaj, MD, FACS, A Medical Corporation on 2026-09-09.