Low Level Light Therapy (LLLT) for Hair Growth

The Efficacy of Visible Red Light for Promoting the Growth of Human Scalp Hair for Both Male and Female - An Open-label Study

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.

Study Overview

• Status: Recruiting
• Conditions: Male Pattern Baldness; Female Pattern Baldness
• Intervention / Treatment: Device: low-level laser/light therapy

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elinor Chang; Phone Number: 7134876230; Email: admin@awareable.ai

Study Locations

• United States
  • Maryland
    • Ijamsville, Maryland, United States, 21754
      • Recruiting
      • Will Surgical Arts
      • Contact: Erin Ferreira; Phone Number: 301-874-1707; Email: erin@willsurgicalarts.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Density	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.	14 weeks
Hair Density	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.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Follicle Change	Both individual and all participants' follicles shall be analyzed to determine the percent of change in hair follicle anagen/telogen ratio	14 weeks

Collaborators and Investigators

• Sponsor: Awareable Technologies Inc
• Investigators: Principal Investigator: Michael Will, MD

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: COH02.01

Drug and device information, study documents

• 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.: No