Clinical trial NCT06748287: A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia
Official title: A Clinical Comparison of FDA-Cleared Photobiomodulation Devices for the Treatment of Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alopecia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Investigator's Global Assessment Score (IGA score)
timeFrame: baseline to 5 months
measure: Savin score
timeFrame: baseline to 5 months
measure: Ludwig score
timeFrame: baseline to 5 months
measure: Hamilton-Norwood score
timeFrame: Baseline to 5 months
measure: Dermatologist Evaluation of Scalp Health (Scale)
timeFrame: Baseline to 5 months
measure: Dermatologist Evaluation of Scalp Health (Erythema)
timeFrame: Baseline to 5 months
measure: Dermatologist Evaluation of Scalp Health (Folliculitis)
timeFrame: Baseline to 5 months
measure: Hair Growth Assessment (HGA)
timeFrame: Baseline to 5 months
measure: Hair Growth Index (HGI)
timeFrame: Baseline to 5 months
measure: Hair Growth Satisfaction Surveys (HGSS)
timeFrame: Baseline to 5 months
measure: Subject Scalp Health Assessment (SSHA)
timeFrame: Baseline to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria K Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: