Low Level Light Therapy (LLLT) for Hair Growth

Female Pattern Baldness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938948
• Other study ID #: COH02.01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Baldness
• Male Pattern Baldness

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