Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

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Brief Title

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Official Title

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

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 "photobiomodulation"3.

      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.
    



Study Type

Interventional


Primary Outcome

Target area total hair count at 26 weeks via phototrichogram

Secondary Outcome

 Target area vellus hair count at 26 weeks via phototrichogram

Condition

Androgenetic Alopecia

Intervention

LaserCap SD

Study Arms / Comparison Groups

 Sham LaserCap
Description:  Sham device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

September 2022

Completion Date

August 2024

Primary Completion Date

December 2023

Eligibility Criteria

        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
      

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, (520) 694-8888, [email protected]



Administrative Informations


NCT ID

NCT05365360

Organization ID

LLLT Fluence RCT


Responsible Party

Sponsor

Study Sponsor

University of Arizona

Collaborators

 Transdermal Cap, Inc.

Study Sponsor

, , 


Verification Date

May 2022