Recruiting

LLLT

Sponsor:

Awareable Technologies Inc

Code:

NCT03938948

Conditions

Male Pattern Baldness

Female Pattern Baldness

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

low-level laser/light therapy

Study Details

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.

Conditions

Male Pattern Baldness

Female Pattern Baldness

Study ID

NCT03938948

Start date

Apr 11, 2019

Status verified date

May, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

62 participants shall be enrolled

Interventions

low-level laser/light therapy

Participants will wear light therapy devices for 14 weeks

Primary outcome measure

  • Hair Density [ Time Frame: 14 weeks ]
  • Hair Density [ Time Frame: 14 weeks ]

Central Contacts and Locations

Central contacts

Elinor Chang

7134876230admin@awareable.ai

Locations

Will Surgical Arts

Recruiting

Ijamsville, Maryland, United States, 21754

Contacts

Erin Ferreira

301-874-1707erin@willsurgicalarts.com

More Information

Sponsor

Awareable Technologies Inc

Last update posted

Jun 1, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Awareable Technologies Inc on 2021-06-01.