Low Level Light Device as a Primary Therapy for Androgenetic Alopecia
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|ClinicalTrials.gov Identifier: NCT04558242|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia Hair Loss Thinning Hair Balding||Device: Genix Device: Sham||Not Applicable|
The application of low-level light therapy has aroused considerable research interest in recent years for the treatment of a variety of clinical indications. These range from pain management to wound healing and most recently to hair regrowth. All have demonstrated biological effects in living organisms. In 1967 Endre Mester, a physician practicing in Budapest Hungary, decided to test the effects of laser radiation on mice and its possible link to resultant cancer. To his great surprise, the mice regrew the shaved hair in half the time of non-radiated mice. This was the first reference to LLLT and hair growth.
This study on LLLT, aims to confirm the established safety and physiologic effects that occur when the human hair follicle and surrounding tissue structures are exposed to this type of radiation. Thus far, all reports on the efficacy of low level light therapy (LED) in this area, have been, in large part, consistent in outcome results, as supported by multi-center, randomized, double blind, controlled studies. This has been in the form of analysis of the non-radiated and radiated tissues as determined by terminal hair counts from baseline to post treatment counts. The theory that is widely accepted is that the mitochondria are the powerhouse of the stem cells that cause hair growth. The LLLT "turns on" the nutrient pump process that energizes the mitochondria, which leads to an increase in ATP and subsequent reversal of hair follicles from the dormant stage of growth called telogen, to the active growth stage called anagen.
This specific light system is unclassified by the FDA, from a radiation standpoint, because the agency has not developed class designations for LEDs. Currently, it is classified as a class II medical device and will be designated as an Over-the-Counter device. It may be marketed for hair regrowth, as defined by an increase in terminal hairs and wellness, which can be defined as thicker, denser, more supple and darker hair shafts.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Active Comparator: Genix LLLT Therapeutic Cap
This is a low-level light device containing 150, 650 nanometer LEDs and 50, 940 nanometer LEDs of equal energy output, fixed at 10 milliwatts in a low profile helmet.
Low Level Light (LEDs)
Sham Comparator: Sham Non-therapeutic Placebo Cap
Sham Placebo Cap low profile helmet containing no low-level light.
Incandescent Bulbs Colored Red
- Terminal Hair Growth [ Time Frame: 24 Weeks ]Terminal hairs from pre-treatment photographs and post-treatment photographs, as defined by the universally accepted description of a terminal hair shaft of the human scalp.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558242
|Contact: Rebecca J Settar, RNemail@example.com|
|Contact: Raymond R Blanchefirstname.lastname@example.org|
|United States, New Jersey|
|NST Consultants, Inc.||Recruiting|
|Mendham, New Jersey, United States, 07945|
|Contact: Rebecca J Settar, RN 973-539-7444 email@example.com|
|Principal Investigator: Adam Bodian, MD|
|Principal Investigator:||Adam Bodian, MD||Bodian Dermatology Group|