Androgenetic AlopeciaNCT04558242
Low Level Light Device as a Primary Therapy for Androgenetic Alopecia
A study testing Genix in people with Androgenetic Alopecia and Hair Loss, run by Kiierr International, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Hair Loss, Thinning Hair
- What is being tested?
- Genix
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NST Consultants, Inc.
Mendham, New Jersey, 07945
Rebecca J Settar, RN, 973-539-7444, rebeccas@nstconsultantsinc.com
Adam Bodian, MD
About this study
Official title: Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women
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.
Read the 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.
- Conditions
- Androgenetic Alopecia, Hair Loss, Thinning Hair, Balding
- Being tested
- Genix, Sham
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenixDevice
Low Level Light (LEDs)
ShamDevice
Incandescent Bulbs Colored Red
| Study group | Role | What they receive |
|---|---|---|
| Genix LLLT Therapeutic Cap | Active comparator | 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. Receives: Device: Genix |
| Sham Non-therapeutic Placebo Cap | Sham comparator | Sham Placebo Cap low profile helmet containing no low-level light. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Aug 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiierr International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Bodian, MD, Principal investigator, Bodian Dermatology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558242
- Sponsor's protocol ID
- DUAL6594
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GENIX, a Low Level Light Device as a Primary Therapy for Androgenetic Alopecia in Men and Women
- ClinicalTrials.gov ID
- NCT04558242
- Acronym / sponsor ID
- DUAL6594
- Conditions
- Androgenetic Alopecia, Hair Loss, Thinning Hair, Balding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kiierr International, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genix LLLT Therapeutic Cap | Active comparator | Device: GenixThis 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 Non-therapeutic Placebo Cap | Sham comparator | Device: ShamSham Placebo Cap low profile helmet containing no low-level light. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenixLow Level Light (LEDs) | Device | Genix LLLT Therapeutic Cap |
| ShamIncandescent Bulbs Colored Red | Device | Sham Non-therapeutic Placebo Cap |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bodian, MD principal investigator
Bodian Dermatology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genix in people with Androgenetic Alopecia and Hair Loss, run by Kiierr International, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca J Settar, RN (973-539-7444, rebeccas@nstconsultantsinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Terminal Hair Growth (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.