Male Pattern BaldnessNCT03938948
Low Level Light Therapy (LLLT) for Hair Growth
A study testing low-level laser/light therapy in people with Male Pattern Baldness and Female Pattern Baldness, run by Awareable Technologies Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Male Pattern Baldness, Female Pattern Baldness
- What is being tested?
- low-level laser/light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Will Surgical Arts
Ijamsville, Maryland, 21754
Erin Ferreira, 301-874-1707, erin@willsurgicalarts.com
About this study
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
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
- Being tested
- low-level laser/light therapy
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser/light therapyDevice
Participants will wear light therapy devices for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 62 participants shall be enrolled Receives: Device: low-level laser/light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 weeks
Secondary outcomes (1)
Hair Follicle Change
Both individual and all participants' follicles shall be analyzed to determine the percent of change in hair follicle anagen/telogen ratio
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start11 Apr 2019
- Primary completion31 Dec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Awareable Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Will, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938948
- Sponsor's protocol ID
- COH02.01
- Status last verified
- May 2021
- First submitted
- 3 May 2019
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03938948
- Acronym / sponsor ID
- COH02.01
- Conditions
- Male Pattern Baldness, Female Pattern Baldness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Awareable Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: low-level laser/light therapy62 participants shall be enrolled |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laser/light therapyParticipants will wear light therapy devices for 14 weeks | Device | Treatment Arm |
Primary outcome
Hair Density
Time frame: 14 weeks
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
Time frame: 14 weeks
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.
1 secondary outcome
Hair Follicle Change
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
Related trials for Male Pattern Baldness
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Active, not recruitingPhase 3
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Androgenetic Alopecia, Female Pattern Baldness
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
RecruitingPhase 2/3
Phase 2/3 Efficacy and Safety of PP405 in Adult Males
Androgenetic Alopecia
RecruitingPhase 1/2
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
Androgenetic Alopecia (AGA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Will, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser/light therapy in people with Male Pattern Baldness and Female Pattern Baldness, run by Awareable Technologies Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elinor Chang (7134876230 ext. 0, admin@awareable.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Density (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.