AlopeciaEarly Phase 1NCT06748287
A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia
A Early Phase 1 study testing iGrow Hair Growth System, Capillus352 and HairMax Ultima 12 Lasercomb in people with Alopecia, run by University of Minnesota at 1 site in United States.
Trial summary
Photobiomodulation is a form of non-ionizing light therapy has been shown to stimulate cellular processes and reduce inflammation as well as improve pain and wound healing. Photobiomodulation has also been found to enhance fibroblast growth factor production. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Alopecia
- What is being tested?
- iGrow Hair Growth System, Capillus352 and HairMax Ultima 12 Lasercomb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 1 Feb 2023
- Phase
- Early Phase 1
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ages 21-85 years old with alopecia.
- Prospective subjects must be in good general health.
- Female subjects who are premenopausal and of childbearing capacity must use oral contraceptive tablets, implanted contraceptive hormones, or Depo-Provera® contraceptive injections as birth control for the duration of the study.
- If prospective subjects are on hormone-containing medication, they must be on stable dose for past 6 months.
- Willing to abstain from use of over-the-counter hair products such as topical Minoxidil (Rogaine ® ) and prescription hair products.
- Willing to use DHS zinc shampoo and conditioner for the duration of the study.
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- Willing to avoid using any hair styling products directly on the scalp.
- Subjects must be capable of giving informed consent.
- Willing to adhere to protocol, including scalp examinations, questionnaires, and photography.
- Willing to adhere to treatment protocol and frequency used for FDA clearance.
- Willing to retain the same hair style and color throughout the duration of the study.
- Willing to shampoo/clean scalp at least 3 times per week.
Who cannot join
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, or HIV)
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks.
- Systemic administration of corticosteroid or other systemic treatment (i.e., prednisone) that has immunomodulatory or other immunosuppressive mechanisms of action, in the preceding 3 months or planned usage throughout the study.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Other scalp conditions (i.e., seborrheic dermatitis or dissecting cellulitis) that might interfere with evaluations during the study.
- Investigational medications within the past 30 days.
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- Female prospective subject is pregnant, nursing, planning a pregnancy, or less than six months postpartum.
- Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
- Use of photobiomodulating device, such as those in this study, within the past 4 weeks
- Initiation or change in dose/application of topical minoxidil within the past 6 weeks.
- Finasteride or dutasteride within the last 3 months.
- Spironolactone within the past 3 months.
- Vitamin supplementation (i.e. selenium, or biotin) in excess of daily recommendation per manufacturer.
- Lesions in the treated area suspicious for malignancy, or prior skin cancer.
- Radiation or chemotherapy to the scalp.
- Use of topical or oral ketoconazole in the past 4 weeks.
- Hair transplant procedure within the past 6 months or throughout the duration of the study.
- History of microneedling procedure performed on scalp.
- Changes in hair style while enrolled in the study.
- Current weave, or plans to get a weave while enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Photobiomodulation is a form of non-ionizing light therapy has been shown to stimulate cellular processes and reduce inflammation as well as improve pain and wound healing. Photobiomodulation has also been found to enhance fibroblast growth factor production. A challenge in clinic is to answer the patients' questions regarding which FDA-cleared device is the best to purchase. Therefore, this study was designed to gain experience with the use of the following devices and to clinically evaluate their efficacy: iGrow Hair Growth System, Capillus352, Hair Max Ultima 12 LaserComb, and HairMax Laserband 82. The purpose of this pilot research study is to clinically compare and evaluate FDA-cleared photobiomodulation devices after four months of treatment and one-month follow-up in subjects with alopecia.
- Conditions
- Alopecia
- Being tested
- iGrow Hair Growth System, Capillus352, HairMax Ultima 12 Lasercomb, HairMax Laserband 82
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iGrow Hair Growth SystemDevice
has a helmet-design and headphones to allow for hands-free use and music listening capabilities. Treatment is 25 minutes every other day. three to four times per week for 4 months.
Capillus352Device
has a similar design to a salon hair dryer which hovers over the head to allow for hand-free use. Treatment is 12 minutes, three times per week for 4 months.
HairMax Ultima 12 LasercombDevice
is comb-like device with hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 8 minutes three times per week for 4 months.
HairMax Laserband 82Device
is headband design device which has unique hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 90-second treatments three times per week for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| iGrow Hair Growth System | Experimental | male or female subjects ages 21-85 with alopecia randomized to use iGrow Hair Growth System photobiomodulation device. Receives: Device: iGrow Hair Growth System |
| Capillus352 | Active comparator | male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device. Receives: Device: Capillus352 |
| HairMax Ultima 12 Lasercomb | Experimental | male or female subjects ages 21-85 with alopecia randomized to use HairMax Ultima 12 Lasercomb photobiomodulation device. Receives: Device: HairMax Ultima 12 Lasercomb |
| HairMax Laserband 82 | Experimental | male or female subjects ages 21-85 with alopecia randomized to use HairMax Laserband 82 photobiomodulation device. Receives: Device: HairMax Laserband 82 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment Score (IGA score)
Units on a scale. Standardized rating system used in research to assess various dermatologic conditions, including hair loss (-3-+3). It involves visual examination by trained board-certified dermatologists to evaluate specific criteria assessing the overall severity of hair loss.
Measured: baseline to 5 months
Savin score
Units on a scale. Classification systems for female pattern hair loss (I-1-III) severity, assessed during monthly examinations.
Measured: baseline to 5 months
Ludwig score
Units on a scale. Classification system for female pattern hair loss (I-III) severity, assessed during monthly examinations.
Measured: baseline to 5 months
Hamilton-Norwood score
Units on a scale. Classification systems for male pattern hair loss (I-VII) severity, assessed during monthly examinations.
Measured: Baseline to 5 months
Dermatologist Evaluation of Scalp Health (Scale)
Scalp health, specifically scale, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Measured: Baseline to 5 months
Dermatologist Evaluation of Scalp Health (Erythema)
Dermatologist Evaluation of Scalp Health (Erythema) Description: Scalp health, specifically erythema, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Measured: Baseline to 5 months
Dermatologist Evaluation of Scalp Health (Folliculitis)
Scalp health, specifically folliculitis, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Measured: Baseline to 5 months
Hair Growth Assessment (HGA)
Units on a scale. A scale used to describe scalp hair growth progress compared to baseline photos. Change is quantified on a scale of -3 to 3.
Measured: Baseline to 5 months
Hair Growth Index (HGI)
Units on a scale. Hair growth is evaluated using three self-assessment questions on a scale of -3 to 3.
Measured: Baseline to 5 months
Hair Growth Satisfaction Surveys (HGSS)
Units on a scale. Participant satisfaction with hair appearance/growth compared to baseline across five questions on a scale of -3 to 3.
Measured: Baseline to 5 months
Subject Scalp Health Assessment (SSHA)
Units on a scale. Self-assessment of scalp health and hair condition through multiple questions measured on a scale of -2 to 2 during monthly exams.
Measured: Baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Jan 2017
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria K Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748287
- Sponsor's protocol ID
- DERM-2017-25394
- Status last verified
- Dec 2024
- First submitted
- 26 Apr 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia
- ClinicalTrials.gov ID
- NCT06748287
- Acronym / sponsor ID
- DERM-2017-25394
- Conditions
- Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 27 Dec 2024 (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.
Photobiomodulation is a form of non-ionizing light therapy has been shown to stimulate cellular processes and reduce inflammation as well as improve pain and wound healing. Photobiomodulation has also been found to enhance fibroblast growth factor production. A challenge in clinic is to answer the patients' questions regarding which FDA-cleared device is the best to purchase. Therefore, this study was designed to gain experience with the use of the following devices and to clinically evaluate their efficacy: iGrow Hair Growth System, Capillus352, Hair Max Ultima 12 LaserComb, and HairMax Laserband 82. The purpose of this pilot research study is to clinically compare and evaluate FDA-cleared photobiomodulation devices after four months of treatment and one-month follow-up in subjects with alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iGrow Hair Growth System | Experimental | Device: iGrow Hair Growth Systemmale or female subjects ages 21-85 with alopecia randomized to use iGrow Hair Growth System photobiomodulation device. |
| Capillus352 | Active comparator | Device: Capillus352male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device. |
| HairMax Ultima 12 Lasercomb | Experimental | Device: HairMax Ultima 12 Lasercombmale or female subjects ages 21-85 with alopecia randomized to use HairMax Ultima 12 Lasercomb photobiomodulation device. |
| HairMax Laserband 82 | Experimental | Device: HairMax Laserband 82male or female subjects ages 21-85 with alopecia randomized to use HairMax Laserband 82 photobiomodulation device. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female ages 21-85 years old with alopecia.
- Prospective subjects must be in good general health.
- Female subjects who are premenopausal and of childbearing capacity must use oral contraceptive tablets, implanted contraceptive hormones, or Depo-Provera® contraceptive injections as birth control for the duration of the study.
- If prospective subjects are on hormone-containing medication, they must be on stable dose for past 6 months.
- Willing to abstain from use of over-the-counter hair products such as topical Minoxidil (Rogaine ® ) and prescription hair products.
Key exclusion criteria (20 listed)
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, or HIV)
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks.
- Systemic administration of corticosteroid or other systemic treatment (i.e., prednisone) that has immunomodulatory or other immunosuppressive mechanisms of action, in the preceding 3 months or planned usage throughout the study.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Other scalp conditions (i.e., seborrheic dermatitis or dissecting cellulitis) that might interfere with evaluations during the study.
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 |
|---|---|---|
| iGrow Hair Growth Systemhas a helmet-design and headphones to allow for hands-free use and music listening capabilities. Treatment is 25 minutes every other day. three to four times per week for 4 months. | Device | iGrow Hair Growth System |
| Capillus352has a similar design to a salon hair dryer which hovers over the head to allow for hand-free use. Treatment is 12 minutes, three times per week for 4 months. | Device | Capillus352 |
| HairMax Ultima 12 Lasercombis comb-like device with hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 8 minutes three times per week for 4 months. | Device | HairMax Ultima 12 Lasercomb |
| HairMax Laserband 82is headband design device which has unique hair-parting teeth to aid in delivery of light therapy directly to the scalp. Treatment is 90-second treatments three times per week for 4 months. | Device | HairMax Laserband 82 |
Primary outcome
Investigator's Global Assessment Score (IGA score)
Time frame: baseline to 5 months
Units on a scale. Standardized rating system used in research to assess various dermatologic conditions, including hair loss (-3-+3). It involves visual examination by trained board-certified dermatologists to evaluate specific criteria assessing the overall severity of hair loss.
Savin score
Time frame: baseline to 5 months
Units on a scale. Classification systems for female pattern hair loss (I-1-III) severity, assessed during monthly examinations.
Ludwig score
Time frame: baseline to 5 months
Units on a scale. Classification system for female pattern hair loss (I-III) severity, assessed during monthly examinations.
Hamilton-Norwood score
Time frame: Baseline to 5 months
Units on a scale. Classification systems for male pattern hair loss (I-VII) severity, assessed during monthly examinations.
Dermatologist Evaluation of Scalp Health (Scale)
Time frame: Baseline to 5 months
Scalp health, specifically scale, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Dermatologist Evaluation of Scalp Health (Erythema)
Time frame: Baseline to 5 months
Dermatologist Evaluation of Scalp Health (Erythema) Description: Scalp health, specifically erythema, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Dermatologist Evaluation of Scalp Health (Folliculitis)
Time frame: Baseline to 5 months
Scalp health, specifically folliculitis, is evaluated and marked as "absent", "mild", or "moderate" by a board-certified dermatologist during monthly examinations.
Hair Growth Assessment (HGA)
Time frame: Baseline to 5 months
Units on a scale. A scale used to describe scalp hair growth progress compared to baseline photos. Change is quantified on a scale of -3 to 3.
Hair Growth Index (HGI)
Time frame: Baseline to 5 months
Units on a scale. Hair growth is evaluated using three self-assessment questions on a scale of -3 to 3.
Hair Growth Satisfaction Surveys (HGSS)
Time frame: Baseline to 5 months
Units on a scale. Participant satisfaction with hair appearance/growth compared to baseline across five questions on a scale of -3 to 3.
Subject Scalp Health Assessment (SSHA)
Time frame: Baseline to 5 months
Units on a scale. Self-assessment of scalp health and hair condition through multiple questions measured on a scale of -2 to 2 during monthly exams.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
Maria K Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing iGrow Hair Growth System, Capillus352 and HairMax Ultima 12 Lasercomb in people with Alopecia, run by University of Minnesota 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 27 Dec 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Global Assessment Score (IGA score) (time frame: baseline to 5 months). The study lists 11 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 27 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.