A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males
1 other identifier
interventional
N/A
1 country
3
Brief Summary
The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively perform self-use application by following written instructions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 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
Primary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedFebruary 20, 2014
February 1, 2014
February 12, 2014
February 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in terminal hair count in the target region
A circular haircount target area approximately 1.9 cm in diameter will be identified between 10 and 2 o'clock in the leading edge of an actively balding area of the vertex. The target area will be clipped short (approximately 1 mm in length). A small dot tattoo will be placed in the center of the target area and will be used as a reference point. The same circular haircount area will be clipped and photographed at subsequent study visits. All hairs \>30 μM will be classified as terminal hairs. The number of terminal hair counts (n/cm2) and width of terminal hairs (μM/cm2) in the hair count area will be measured at the baseline, subsequent study visits and at 26 weeks.
26 weeks
Secondary Outcomes (1)
Subject's static self global assessment of hair regrowth
26 weeks
Study Arms (2)
X5 HairLaser
ACTIVE COMPARATORX5 HairLaser Sham Device
SHAM COMPARATORInterventions
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Eligibility Criteria
You may qualify if:
- Male with a diagnosis of Androgenetic Alopecia according to the Guidelines of the American Academy of Dermatology
- Experiencing active hair loss within the last 12 months.
- In general good health
- Norwood-Hamilton classification of 3, 3A, 3V, 4, 4A, or 5
- Skin Type I, II, III or IV on the Fitzpatrick Skin Type Scale
- Between 20 and 60 years of age at the time of enrollment
- Willing to have a dot tattoo placed on or around the target area of the scalp
- Willing to maintain the same hairstyle, approximate hair length and hair color throughout the study.
- Willing to continue his current regimen of vitamis and nutritional supplements and not start any new vitamins or nutritional supplements for the duration of the study.
- Must be able to read, understand provide written (signed) informed consent after the nature of the study has been fully explained and before any procedures dictated by this protocol are performed.
- Prospective subjects must be willing and able to comply with follow up requirements, including adhering to scheduled office visits in a timely manner.
- Must be fluent in English.
You may not qualify if:
- Prospective subject has an active malignancy of any type or history of any malignancy, including any malignancy in the treatment area in the past 5 years.
- History of hypogonadism.
- Has used phytotherapy within in eight weeks prior to baseline.
- Has any active skin infection in the scalp area or scarring in the target area.
- Has photosensitivity to laser light.
- Has used Accutane in the previous year.
- Has a history of poor wound healing.
- Has a history of keloid formation.
- Has a known history of anticoagulant or antiplatelet use.
- Has used or currently takes any of the following medications during the six months prior to screening: finasteride (or any other 5a-reductase inhibitor medications), medications with anti-androgenic properties, topical estrogen, progesterone, tamoxifen, anabolic steroids, medications which can potential cause hypertrichosis, oral glucocorticoids, lithium, phenothiazines, or other medication at the discretion of the investigator
- Has used or currently takes Minoxidil during 12 months prior to screening.
- Has "buzz" cut hairstyle, defined as hair cut to less than one inch in length.
- Has light blond, light gray or white hair, at the discretion of the investigator.
- Has a chronic dermatological condition (eczema, psoriasis, infection, etc) of the scalp other than male pattern hair loss.
- Has a pacemaker.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Hilltop Research
St. Petersburg, Florida, 33710, United States
NYU School of Medicine
New York, New York, 10003, United States
Related Publications (1)
Blum K, Han D, Madigan MA, Lohmann R, Braverman ER. "Cold" X5 Hairlaser used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. BMC Res Notes. 2014 Feb 24;7:103. doi: 10.1186/1756-0500-7-103.
PMID: 24559020DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 20, 2014
Primary Completion
April 1, 2010
Last Updated
February 20, 2014
Record last verified: 2014-02