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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03938948
Other study ID # COH02.01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2019
Est. completion date December 2022

Study information

Verified date May 2021
Source Awareable Technologies Inc
Contact Elinor Chang
Phone 7134876230
Email admin@awareable.ai
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date December 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Device:
low-level laser/light therapy
Participants will wear light therapy devices for 14 weeks

Locations

Country Name City State
United States Will Surgical Arts Ijamsville Maryland

Sponsors (1)

Lead Sponsor Collaborator
Awareable Technologies Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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