A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males

NCT ID: NCT02067260

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Androgenetic Alopecia

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

X5 HairLaser

Group Type: ACTIVE_COMPARATOR

X5 HairLaser

Intervention Type: DEVICE

Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.

X5 HairLaser Sham Device

Group Type: SHAM_COMPARATOR

X5 Hair Laser Sham Device

Intervention Type: DEVICE

Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.

Interventions

X5 HairLaser

Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.

Intervention Type: DEVICE

X5 Hair Laser Sham Device

Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Has had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform hair count assessment.
• Has ever received radiation therapy to the scalp, or has had chemotherapy in the past year.
• Has a known underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
• Has participated in any investigational study within 30 days prior to randomization.
• Has a history or evidence of drug and/or alcohol abuse within the 12 months prior to Visit 1.
• Has a history or the presence of any serious and/or chronic medical condition(s) which, in the opinion of the investigator, may cause harm to the individual and/or compromise/confound the study results.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Spencer Forrest, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Hilltop Research

St. Petersburg, Florida, United States

NYU School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24559020 (View on PubMed)

Other Identifiers

08-02-31-161

Identifier Type: -

Identifier Source: org_study_id