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

December 20, 2024 updated by: University of Minnesota
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Active Comparator: Capillus352
male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device.
Device: Capillus352
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.
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
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.
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
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 is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline to 5 months
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.
baseline to 5 months
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.
baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months
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.
Baseline to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria K Hordinsky, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DERM-2017-25394

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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