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

NCT ID: NCT06748287

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2023-02-01

Brief 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

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iGrow Hair Growth System

male or female subjects ages 21-85 with alopecia randomized to use iGrow Hair Growth System photobiomodulation device.

Group Type: EXPERIMENTAL

iGrow Hair Growth System

Intervention Type: DEVICE

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.

Capillus352

male or female subjects ages 21-85 with alopecia randomized to use Capillus352 photobiomodulation device.

Group Type: ACTIVE_COMPARATOR

Capillus352

Intervention Type: DEVICE

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 Lasercomb

male or female subjects ages 21-85 with alopecia randomized to use HairMax Ultima 12 Lasercomb photobiomodulation device.

Group Type: EXPERIMENTAL

HairMax Ultima 12 Lasercomb

Intervention Type: DEVICE

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 82

male or female subjects ages 21-85 with alopecia randomized to use HairMax Laserband 82 photobiomodulation device.

Group Type: EXPERIMENTAL

HairMax Laserband 82

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria K Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

DERM-2017-25394

Identifier Type: -

Identifier Source: org_study_id