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

NCT06748287 | Completed Early Phase 1 FDA Device

• 1 other identifier: DERM-2017-25394
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  baseline to 5 months

• Ludwig score

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (4)

iGrow Hair Growth System

EXPERIMENTAL

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

Device: iGrow Hair Growth System

Capillus352

ACTIVE COMPARATOR

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

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.

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.

Device: HairMax Laserband 82

Interventions

iGrow Hair Growth System 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.

iGrow Hair Growth System

Capillus352 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.

Capillus352

HairMax Ultima 12 Lasercomb 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 Ultima 12 Lasercomb

HairMax Laserband 82 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.

HairMax Laserband 82

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria K Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: December 27, 2024
• Study Start: January 3, 2017
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)