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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Low Level Light Therapy (LLLT) for Hair Growth

Clinicaltrials.gov identifier NCT03938948

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

Brief summary:

A total of 62 participants will receive red light (660 nm) to the scalp through a specially designed light therapy device integrated into a conventional hat. Each treatment will be 30 min per session applied on every other day for 14 weeks.

  • Condition or Disease:Male Pattern Baldness
    Female Pattern Baldness
  • Intervention/Treatment: Device: low-level laser/light therapy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 62 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Efficacy of Visible Red Light for Promoting the Growth of Human Scalp Hair for Both Male and Female - An Open-label Study
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Treatment Arm
62 participants shall be enrolled
Device: low-level laser/light therapy
Participants will wear light therapy devices for 14 weeks
Outcome Measures
  • Primary Outcome Measures: 1. Hair Density [ Time Frame: 14 weeks ]
    Individual participant's hair density will be measured at the end of 14 weeks and compared with the baseline density measure at the start of the treatment.
  • 2. Hair Density [ Time Frame: 14 weeks ]
    Mean hair density for the participants after 14 weeks will be compiled and compared with the mean density of the participants' at the start of the study to determine changes.
  • Secondary Outcome Measures: 1. Hair Follicle Change [ Time Frame: 14 weeks ]
    Both individual and all participants' follicles shall be analyzed to determine the percent of change in hair follicle anagen/telogen ratio
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Male or female subjects between the ages of 18 and 60 years

- Diagnosed AGA in the past 12 months for male (Fitzpatrick I-IV, Hamilton-Norwood IIa-V
) and female (Fitzpatrick I-IV, and Ludwig-Savin Baldness Scale I-2, I-3, I-4, II-1,
II-2 baldness patterns)

Exclusion Criteria:

- Known Photosensitivity

- Using any oral or topical substance for hair growth

- Having Tattoo, hair transplantation, scalp reduction, malignancy or hair weave in the
scalp are with alopecia

- Known medical conditions that could negatively affect hair growth, such as infections,
connective tissue disease

- Currently or plan to be on a calorie-restricted diet during study participation

Contacts and Locations
Contacts

Contact: Elinor Chang 6507282300 ext 813 zmz998100@gmail.com

Locations

United States, Maryland
Will Surgical Arts
Ijamsville

Sponsors and Collaborators

Awareable Technologies Inc

Investigators

Principal Investigator: Michael Will, MD

More Information
  • Responsible Party: Awareable Technologies Inc
  • ClinicalTrials.gov Identifier: NCT03938948 History of Changes
  • Other Study ID Numbers: COH02.01
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 6, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Alopecia Alopecia Areata