Recruiting

Low Level Light Device

Sponsor:

Kiierr International, LLC

Code:

NCT04558242

Conditions

Androgenetic Alopecia

Hair Loss

Thinning Hair

Balding

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Genix

Sham

Study Details

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.

Conditions

Androgenetic Alopecia

Hair Loss

Thinning Hair

Balding

Study ID

NCT04558242

Start date

Aug 1, 2020

Status verified date

Sep, 2020

Completion date

Aug 1, 2021

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

sham comparator: Sham Non-therapeutic Placebo Cap

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

Interventions

Genix

Low Level Light (LEDs)

Sham

Incandescent Bulbs Colored Red

Primary outcome measure

  • Terminal Hair Growth [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Rebecca J Settar, RN

973-539-7444rebeccas@nstconsultantsinc.com

Raymond R Blanche

973-417-8675raymond@nstconsultantsinc.com

Locations

NST Consultants, Inc.

Recruiting

Mendham, New Jersey, United States, 07945

Contacts

Rebecca J Settar, RN

973-539-7444rebeccas@nstconsultantsinc.com

Principal Investigator:

Adam Bodian, MD

More Information

Sponsor

Kiierr International, LLC

Last update posted

Sep 22, 2020

Last verified

Sep, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kiierr International, LLC on 2020-09-22.