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Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia, Hair Loss, Thinning Hair

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Genix

Sham

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males- age 18-50, females 18 - 70 having Fitzpatrick skin types I-VI.
Androgenetic alopecia by history and clinical examination. Norwood-Hamilton Class (IIa-V) and Ludwig-Savin I-II
Having good health and not belonging to any risk group for possible immunodeficiency of other chronic systemic diseases that affect hair.
Have a healthy scalp with no anatomical abnormality or suffering with any cutaneous disorder that would preclude participation in this study. Subjects suffering with dermatological conditions such as seborrheic dermatitis or psoriasis can participate provided the scalp is not involved, and no topical treatment is being administered to the scalp during the expected period of treatment.
Willingness to answer questions related to Safety and Adverse Effects after each treatment.
Willingness to have the required physical examination performed, for the purpose of evaluating general health.
Willing to refrain from using any other topical preparation to restore hair, or be involved in any treatment aimed at hair restoration. Having participated in any such treatment will require a 4-week washout period before commencing study.

Exclusion Criteria:

Family history of malignant melanoma, or any cutaneous cancer in the head and neck area.
Past medical history of malignant melanoma, or other cutaneous neoplasm in the head and neck area.
Past Medical History or Family History of Alopecia Areata, or other causes of alopecia, or cancer.
Past medical history of collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp. (Seborrheic dermatitis or psoriasis under good control with therapy and without showing scalp involvement and not requiring topical scalp therapy would not be a contraindication.)
Severe androgenetic alopecia (beyond Norwood-Hamilton V or Ludwig-Savin II).
Previous scalp surgery or signs of any scar on the scalp.
Taking chemotherapeutic agents, bronchodilators, decongestants, antiepileptic, systemic steroids, topical steroids on the scalp or on greater than 10% body surface area or any medication known to cause hair growth.
Having any chronic eye illness, including cataracts, glaucoma, any form of retinal eye disease.

Sites / Locations

NST Consultants, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Genix LLLT Therapeutic Cap

Sham Non-therapeutic Placebo Cap

Arm Description

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.

Sham Placebo Cap low profile helmet containing no low-level light.

Outcomes

Primary Outcome Measures

Terminal Hair Growth

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04558242

First Posted

September 14, 2020

Last Updated

September 21, 2020

Sponsor

Kiierr International, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04558242

Brief Title

Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

Official Title

Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kiierr International, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia, Hair Loss, Thinning Hair, Balding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Genix LLLT Therapeutic Cap

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham Non-therapeutic Placebo Cap

Arm Type

Sham Comparator

Arm Description

Sham Placebo Cap low profile helmet containing no low-level light.

Intervention Type

Device

Intervention Name(s)

Genix

Intervention Description

Low Level Light (LEDs)

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Incandescent Bulbs Colored Red

Primary Outcome Measure Information:

Title

Terminal Hair Growth

Description

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.

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males- age 18-50, females 18 - 70 having Fitzpatrick skin types I-VI. Androgenetic alopecia by history and clinical examination. Norwood-Hamilton Class (IIa-V) and Ludwig-Savin I-II Having good health and not belonging to any risk group for possible immunodeficiency of other chronic systemic diseases that affect hair. Have a healthy scalp with no anatomical abnormality or suffering with any cutaneous disorder that would preclude participation in this study. Subjects suffering with dermatological conditions such as seborrheic dermatitis or psoriasis can participate provided the scalp is not involved, and no topical treatment is being administered to the scalp during the expected period of treatment. Willingness to answer questions related to Safety and Adverse Effects after each treatment. Willingness to have the required physical examination performed, for the purpose of evaluating general health. Willing to refrain from using any other topical preparation to restore hair, or be involved in any treatment aimed at hair restoration. Having participated in any such treatment will require a 4-week washout period before commencing study. Exclusion Criteria: Family history of malignant melanoma, or any cutaneous cancer in the head and neck area. Past medical history of malignant melanoma, or other cutaneous neoplasm in the head and neck area. Past Medical History or Family History of Alopecia Areata, or other causes of alopecia, or cancer. Past medical history of collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp. (Seborrheic dermatitis or psoriasis under good control with therapy and without showing scalp involvement and not requiring topical scalp therapy would not be a contraindication.) Severe androgenetic alopecia (beyond Norwood-Hamilton V or Ludwig-Savin II). Previous scalp surgery or signs of any scar on the scalp. Taking chemotherapeutic agents, bronchodilators, decongestants, antiepileptic, systemic steroids, topical steroids on the scalp or on greater than 10% body surface area or any medication known to cause hair growth. Having any chronic eye illness, including cataracts, glaucoma, any form of retinal eye disease.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca J Settar, RN

Phone

973-539-7444

rebeccas@nstconsultantsinc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Raymond R Blanche

Phone

973-417-8675

raymond@nstconsultantsinc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Bodian, MD

Organizational Affiliation

Bodian Dermatology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

NST Consultants, Inc.

City

Mendham

State/Province

New Jersey

ZIP/Postal Code

07945

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca J Settar, RN

Phone

973-539-7444

rebeccas@nstconsultantsinc.com

First Name & Middle Initial & Last Name & Degree

Adam Bodian, MD

12. IPD Sharing Statement

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Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

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