Clinical Trials Logo

Clinical Trial Summary

The purpose of this research is to study the safety and effectiveness of a light therapy device for human hair growth. This device, called the GENIX, is a type of cold, or non-heat producing light emitting diode (LED) that will emit light on the hair growth cells within and around the hair follicle. When these cells do not function properly, one may experience common problems such as baldness and thinning or brittle hair. The application of a special category of low-level non-laser light to be studied in the project may cause an increase in essential nutrients to the damaged hair follicles and skin cells, leading to a reduction in hair loss and in some cases, possibly leading to re-growth.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

NCT number NCT04558242
Study type Interventional
Source Kiierr International, LLC
Contact Rebecca J Settar, RN
Phone 973-539-7444
Status Recruiting
Phase N/A
Start date August 1, 2020
Completion date August 1, 2021

See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A