Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Androgenetic Alopecia, Hair Loss, Thinning Hair, Balding

In brief

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.

Key facts

Study ID

NCT04558242

Run by

Kiierr International, LLC

People needed

50

Starts

2020-08-01

Expected to finish

2021-08-01

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NST Consultants, Inc. — Mendham, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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