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
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2019
CompletedFirst Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 1, 2021
May 1, 2021
2.7 years
May 3, 2019
May 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Hair Follicle Change
14 weeks
Study Arms (1)
Treatment Arm
EXPERIMENTAL62 participants shall be enrolled
Interventions
Participants will wear light therapy devices for 14 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Will Surgical Arts
Ijamsville, Maryland, 21754, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Will, MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 6, 2019
Study Start
April 11, 2019
Primary Completion
December 31, 2021
Study Completion
December 1, 2022
Last Updated
June 1, 2021
Record last verified: 2021-05