LLLT for Alopecia of the Eyebrow in Women
Evaluation of Low Level Light Therapy (LLLT) as a Primary Therapy for Non-Specific Alopecia of the Eyebrow in Women
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 21, 2021
CompletedMay 21, 2021
May 1, 2021
3 months
May 18, 2021
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in number of terminal hairs
Pre \& Post treatment terminal hair counts
12 weeks
Study Arms (2)
LLLT Active Treatment
EXPERIMENTALLLLT Therapy will be administered to the treatment site.
No LLLT Comparator
NO INTERVENTIONNo LLLT Therapy will be administered to the comparator site.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female subjects experiencing any type of non-traumatic eyebrow hair loss.
- Apparent good health.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NST Consultants, Inc.
Mendham, New Jersey, 07945, United States
Bodian Dermatology
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Bodian, MD
Bodian Dermatology Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 21, 2021
Study Start
May 1, 2019
Primary Completion
August 1, 2019
Study Completion
October 1, 2019
Last Updated
May 21, 2021
Record last verified: 2021-05