CompletedNCT06748287Updated Dec 27, 2024

A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia

An Early Phase 1 interventional study of iGrow Hair Growth System and Capillus352 in Alopecia, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2023, 3 years 8 months ago, and no results have been posted to the registry.
Registered 7 years 3 months after the study started (first participant enrolled Jan 2017, registered Apr 2024).

Phase: Early Phase 1
Study type: Interventional
Enrollment: 104
Allocation: Randomized
Ages: 21 Years to 85 Years
Sex: All

Study 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. 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 studied

Alopecia

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Alopecia 615

In context

Alopecia

615 studies on the registry are indexed under Alopecia; 132 are open to participants now.

This study's enrollment of 104 is above the median of 45 across 516 interventional studies indexed under Alopecia.

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Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 104 participants (actual)

Study arms

Experimental
iGrow Hair Growth System
male or female subjects ages 21-85 with alopecia randomized to use iGrow Hair Growth System photobiomodulation device.
Device: iGrow Hair Growth System
Active comparator
Capillus352
male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device.
Device: Capillus352
Experimental
HairMax Ultima 12 Lasercomb
male or female subjects ages 21-85 with alopecia randomized to use HairMax Ultima 12 Lasercomb photobiomodulation device.
Device: HairMax Ultima 12 Lasercomb
Experimental
HairMax Laserband 82
male or female subjects ages 21-85 with alopecia randomized to use HairMax Laserband 82 photobiomodulation device.
Device: HairMax Laserband 82

Interventions

DeviceiGrow Hair Growth System
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.
DeviceCapillus352
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.
DeviceHairMax Ultima 12 Lasercomb
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.
DeviceHairMax Laserband 82
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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: baseline to 5 months
Ludwig score
Units on a scale. Classification system for female pattern hair loss (I-III) severity, assessed during monthly examinations.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 5 months

Study locations

1 site

University of Minnesota
Minneapolis, Minnesota 55455, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Feb 2023, 72 months.

Of 37 phase 1 interventional studies under Alopecia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 72 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 26, 2024
First posted: Dec 27, 2024
StartActual: Jan 3, 2017
Primary completionActual: Feb 1, 2023
CompletionActual: Feb 1, 2023
Last update: Dec 27, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06748287
Lead sponsor: University of Minnesota
Responsible party: Sponsor
First posted: Dec 27, 2024
Start date: Jan 3, 2017
Primary completion: Feb 1, 2023
Completion: Feb 1, 2023
Last update: Dec 27, 2024

Study contacts

Maria K Hordinsky, MD

principal investigator · University of Minnesota

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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