Androgenetic AlopeciaNCT05365360
Sham LaserCap vs. LaserCap SD vs. LaserCap HD+
A study testing LaserCap SD and LaserCap HD+ in people with Androgenetic Alopecia, run by University of Arizona at 1 site in United States.
Trial summary
Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- LaserCap SD and LaserCap HD+
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to May 2025
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 years and older
- Men and women with AGA, untreated or with 6-month washout of previous treatments
- Men: Norwood stage IIa - V
- Women: Ludwig I-1 - II-2, or frontal pattern
- All patients: Fitzpatrick skin types I to IV
Who cannot join
- Men: Norwood stage Va, VI, VII
- Women: Ludwig stage III, advanced
- All patients: Fitzpatrick skin types V, VI
- Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
- Age 0-25 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Banner University Dermatology
Tucson, Arizona, 85719
Patrick M Jedlowski, MD, 520-621-7168
Patrick M Jedlowski, MD
About this study
Official title: Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial
Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.
In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the ~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.
Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.
- Conditions
- Androgenetic Alopecia
- Being tested
- LaserCap SD, Sham LaserCap, LaserCap HD+
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserCap SDDevice
LaserCap SD
Sham LaserCapDevice
Sham LaserCap
LaserCap HD+Device
LaserCap HD+
| Study group | Role | What they receive |
|---|---|---|
| Sham LaserCap | Sham comparator | Sham device Receives: Device: Sham LaserCap |
| Lasercap SD | Experimental | Low fluence LLLT Receives: Device: LaserCap SD |
| Lasercap HD+ | Experimental | High fluence LLLT Receives: Device: LaserCap HD+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target area total hair count at 26 weeks via phototrichogram
Measured: 26 weeks
Secondary outcomes (4)
Target area vellus hair count at 26 weeks via phototrichogram
Measured: 26 weeks
Target area terminal hair count at 26 weeks via phototrichogram
Measured: 26 weeks
Physician assessed improvement via global photography at 26 weeks
Measured: 26 weeks
Hair growth rate at 26 weeks via phototrichogram
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Transdermal Cap, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365360
- Sponsor's protocol ID
- LLLT Fluence RCT
- Status last verified
- May 2024
- First submitted
- 4 May 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05365360
- Acronym / sponsor ID
- LLLT Fluence RCT
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Transdermal Cap, Inc.
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 9 May 2022 (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.
Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.
In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the ~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.
Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham LaserCap | Sham comparator | Device: Sham LaserCapSham device |
| Lasercap SD | Experimental | Device: LaserCap SDLow fluence LLLT |
| Lasercap HD+ | Experimental | Device: LaserCap HD+High fluence LLLT |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 25 years and older
- Men and women with AGA, untreated or with 6-month washout of previous treatments
- Men: Norwood stage IIa - V
- Women: Ludwig I-1 - II-2, or frontal pattern
- All patients: Fitzpatrick skin types I to IV
Key exclusion criteria (5 listed)
- Men: Norwood stage Va, VI, VII
- Women: Ludwig stage III, advanced
- All patients: Fitzpatrick skin types V, VI
- Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
- Age 0-25 years
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 |
|---|---|---|
| LaserCap SDLaserCap SD | Device | Lasercap SD |
| Sham LaserCapSham LaserCap | Device | Sham LaserCap |
| LaserCap HD+LaserCap HD+ | Device | Lasercap HD+ |
Primary outcome
Target area total hair count at 26 weeks via phototrichogram
Time frame: 26 weeks
4 secondary outcomes
Target area vellus hair count at 26 weeks via phototrichogram
Time frame: 26 weeks
Target area terminal hair count at 26 weeks via phototrichogram
Time frame: 26 weeks
Physician assessed improvement via global photography at 26 weeks
Time frame: 26 weeks
Hair growth rate at 26 weeks via phototrichogram
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaserCap SD and LaserCap HD+ in people with Androgenetic Alopecia, run by University of Arizona 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 5 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 7 May 2024. 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. Some participants in this study may receive a placebo. 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 Patrick Jedlowski, MD ((520) 694-8888, pjedlowski@email.arizona.edi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target area total hair count at 26 weeks via phototrichogram (time frame: 26 weeks). 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 7 May 2024.