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40 Participants NeededMy employer runs this trial

KeraFactor + Revian Light Therapy for Female Pattern Baldness

(KDKR26 Trial)

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: K. Kay Durairaj, MD, FACS, A Medical Corporation

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for women aged 35 to 55 who have been diagnosed with female pattern hair loss (androgenic alopecia).

Inclusion Criteria

Commitment to avoid hair extensions for at least 6 months prior to and throughout the study duration
I have been diagnosed with androgenic alopecia (pattern hair loss).
Willingness to allow trichoscopic and photographic documentation of the scalp and hair
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Exclusion Criteria

History of prolonged or repeated mechanical tension on hair or scalp such as tight hairstyles contributing to traction alopecia
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 underlying medical pathology such as iron deficiency anemia or thyroid dysfunction
Pregnant, breastfeeding, or planning to become pregnant during the study
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What Are the Treatments Tested in This Trial?

Interventions

  • KeraFactor® Solution
  • Revian® LED Light Therapy

Trial Overview

The study tests a scalp-stimulating serum (KeraFactor), a red light therapy cap (Revian Red), both together, or placebo. Participants are randomly assigned to one of four groups and followed for about six months.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Scalp Stimulating Serum + Revian Red CapExperimental Treatment2 Interventions
Group II: Scalp Stimulating Serum OnlyActive Control1 Intervention
Group III: Placebo Solution + Revian Red CapActive Control2 Interventions
Group IV: Placebo ComparatorPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

KeraFactor by SkinQRI

Collaborator

REVIAN, Inc.

Collaborator

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