Androgenetic AlopeciaNCT02067260
A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males
A study testing X5 HairLaser in people with Androgenetic Alopecia, run by Spencer Forrest, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- X5 HairLaser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
NYU School of Medicine
New York, New York, 10003
Hilltop Research
St. Petersburg, Florida, 33710
About this study
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
- Being tested
- X5 HairLaser, X5 Hair Laser Sham Device
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X5 HairLaserDevice
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
X5 Hair Laser Sham DeviceDevice
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| X5 HairLaser | Active comparator | Not described Receives: Device: X5 HairLaser |
| X5 HairLaser Sham Device | Sham comparator | Not described Receives: Device: X5 Hair Laser Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (1)
Subject's static self global assessment of hair regrowth
Subject will report on the following questions, on the following scale:
Not at all, Slight Improvement, Moderate Improvement, Good Improvement, Greatly Improved Has your rate of hair loss slowed down? Do your believe your hair is growing faster? Does your hair feel thicker or fuller? How would you rate the overall improvement of your hair?
The following question will use this scale:
No growth, Minimal Growth, Moderate Growth, Dense Growth How would you rate your overall hair regrowth?
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Spencer Forrest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067260
- Sponsor's protocol ID
- 08-02-31-161
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24559020
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males
- ClinicalTrials.gov ID
- NCT02067260
- Acronym / sponsor ID
- 08-02-31-161
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Spencer Forrest, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Apr 2010 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X5 HairLaser | Active comparator | Device: X5 HairLaser |
| X5 HairLaser Sham Device | Sham comparator | Device: X5 Hair Laser Sham Device |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X5 HairLaserTreatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks. | Device | X5 HairLaser |
| X5 Hair Laser Sham DeviceTreatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks. | Device | X5 HairLaser Sham Device |
Primary outcome
Difference in terminal hair count in the target region
Time frame: 26 weeks
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.
1 secondary outcome
Subject's static self global assessment of hair regrowth
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
- Derived from this study: PubMed 24559020Blum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X5 HairLaser in people with Androgenetic Alopecia, run by Spencer Forrest, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in terminal hair count in the target region (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.