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Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05365360
Enrollment
50
Registered
2022-05-09
Start date
2022-06-01
Completion date
2025-05-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Brief summary

Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1. In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the \ 650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed photobiomodulation3. Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.

Interventions

DEVICELaserCap SD

LaserCap SD

DEVICESham LaserCap

Sham LaserCap

DEVICELaserCap HD+

LaserCap HD+

Sponsors

Transdermal Cap, Inc.
CollaboratorINDUSTRY
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 25 years and older * Men and women with AGA, untreated or with 6-month washout of previous treatments * Men: Norwood stage IIa - V * Women: Ludwig I-1 - II-2, or frontal pattern * All patients: Fitzpatrick skin types I to IV

Exclusion criteria

* Men: Norwood stage Va, VI, VII * Women: Ludwig stage III, advanced * All patients: Fitzpatrick skin types V, VI * Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride * Age 0-25 years

Design outcomes

Primary

MeasureTime frame
Target area total hair count at 26 weeks via phototrichogram26 weeks

Secondary

MeasureTime frame
Target area vellus hair count at 26 weeks via phototrichogram26 weeks
Target area terminal hair count at 26 weeks via phototrichogram26 weeks
Physician assessed improvement via global photography at 26 weeks26 weeks
Hair growth rate at 26 weeks via phototrichogram26 weeks

Countries

United States

Contacts

Primary ContactPatrick Jedlowski, MD
pjedlowski@email.arizona.edi(520) 694-8888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026