Back to resultsLow Level Light Therapy (LLLT) for Hair Growth
Primary Purpose
Male Pattern Baldness, Female Pattern Baldness
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-level laser/light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Male Pattern Baldness
Eligibility 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
Sites / Locations
- Will Surgical ArtsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
62 participants shall be enrolled
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Hair Follicle Change
Both individual and all participants' follicles shall be analyzed to determine the percent of change in hair follicle anagen/telogen ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938948
Brief Title
Low Level Light Therapy (LLLT) for Hair Growth
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Awareable Technologies Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Pattern Baldness, Female Pattern Baldness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
62 participants shall be enrolled
Intervention Type
Device
Intervention Name(s)
low-level laser/light therapy
Intervention Description
Participants will wear light therapy devices for 14 weeks
Primary Outcome Measure Information:
Title
Hair Density
Description
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.
Time Frame
14 weeks
Title
Hair Density
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Hair Follicle Change
Description
Both individual and all participants' follicles shall be analyzed to determine the percent of change in hair follicle anagen/telogen ratio
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elinor Chang
Phone
7134876230
Ext
0
Email
admin@awareable.ai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Will, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Will Surgical Arts
City
Ijamsville
State/Province
Maryland
ZIP/Postal Code
21754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Ferreira
Phone
301-874-1707
Email
erin@willsurgicalarts.com
12. IPD Sharing Statement
Learn more about this trial
Low Level Light Therapy (LLLT) for Hair Growth
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