Low Level Light Device as a Primary Therapy for Androgenetic Alopecia

NCT04558242 | Unknown FDA Device

• 1 other identifier: DUAL6594
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Weeks

Study Arms (2)

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.

Device: Genix

Sham Non-therapeutic Placebo Cap

SHAM COMPARATOR

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

Device: Sham

Interventions

Genix DEVICE

Low Level Light (LEDs)

Genix LLLT Therapeutic Cap

Sham DEVICE

Incandescent Bulbs Colored Red

Sham Non-therapeutic Placebo Cap

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kiierr International, LLC: lead

Study Sites (1)

NST Consultants, Inc.

Mendham, New Jersey, 07945, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Bodian, MD

  Bodian Dermatology Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca J Settar, RN

CONTACT

973-539-7444; rebeccas@nstconsultantsinc.com

Raymond R Blanche

CONTACT

973-417-8675; raymond@nstconsultantsinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 22, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

US (1)