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LLLT for Alopecia of the Eyebrow in Women

Primary Purpose

Alopecia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LLLT
Sponsored by
Freedom Laser Therapy, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female subjects experiencing any type of non-traumatic eyebrow hair loss.
  • Apparent good health.

Exclusion Criteria:

  • Previous involvement in other eyebrow hair studies.
  • Use of any hair growth agent within the last 4 weeks.
  • Evidence of any current viral, fungal or bacterial infection.

Sites / Locations

  • NST Consultants, Inc.
  • Bodian Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LLLT Active Treatment

No LLLT Comparator

Arm Description

LLLT Therapy will be administered to the treatment site.

No LLLT Therapy will be administered to the comparator site.

Outcomes

Primary Outcome Measures

Change in number of terminal hairs
Pre & Post treatment terminal hair counts

Secondary Outcome Measures

Full Information

First Posted
May 18, 2021
Last Updated
May 18, 2021
Sponsor
Freedom Laser Therapy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04897555
Brief Title
LLLT for Alopecia of the Eyebrow in Women
Official Title
Evaluation of Low Level Light Therapy (LLLT) as a Primary Therapy for Non-Specific Alopecia of the Eyebrow in Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Freedom Laser Therapy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research is to study the ongoing effectiveness of a light therapy device for human hair growth. This device, called the iRestore Eyebrow Device, is a type of cold, or non-heat producing light therapy system 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 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
This study on LLLT aims to define the 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 laser light and LED light in this area, have been, in large part, unsupported by multi-center, randomized, double blind, controlled studies. To properly identify the effects in human subjects, exposure to LLLT is not sufficient. The analysis of the non-radiated and radiated tissues is required to elucidate the tissue response and efficacy of the laser therapy. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLLT Active Treatment
Arm Type
Experimental
Arm Description
LLLT Therapy will be administered to the treatment site.
Arm Title
No LLLT Comparator
Arm Type
No Intervention
Arm Description
No LLLT Therapy will be administered to the comparator site.
Intervention Type
Device
Intervention Name(s)
LLLT
Intervention Description
This is a low-level light (LED) device configured in the shape of a headband, operating at 650 +/-10 nanometers and 940 +/- 10 nanometers, that contains 12 of each wavelength for a total of 24 LEDs.
Primary Outcome Measure Information:
Title
Change in number of terminal hairs
Description
Pre & Post treatment terminal hair counts
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female subjects experiencing any type of non-traumatic eyebrow hair loss. Apparent good health. Exclusion Criteria: Previous involvement in other eyebrow hair studies. Use of any hair growth agent within the last 4 weeks. Evidence of any current viral, fungal or bacterial infection.
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
Facility Name
Bodian Dermatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States

12. IPD Sharing Statement

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LLLT for Alopecia of the Eyebrow in Women

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