Androgenetic AlopeciaNCT00947219
Treatment of Androgenic Alopecia in Males
A study testing HairMax LaserComb in people with Androgenetic Alopecia and Hair Loss, run by Lexington International, LLC at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- What is being tested?
- HairMax LaserComb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin Types I-IV
- Norwood-Hamilton IIa to V
- Active hair loss within last 12 months
Who cannot join
- Photosensitivity to laser light
- Malignancy in the target area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
David Goldberg, M.D.
Hackensack, New Jersey, 07601
Zoe Draelos, M.D.
High Point, North Carolina, 27262
Abe Marcadis, M.D.
West Palm Beach, Florida, 33409
About this study
Official title: A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
Read the detailed description
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
- Conditions
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- Being tested
- HairMax LaserComb, Control device
- Keywords
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HairMax LaserCombDevice
Device application 3 times week (non-consecutive days), for 26 weeks
Control deviceDevice
Device is used 3 times a week on non-consecutive days
| Study group | Role | What they receive |
|---|---|---|
| HairMax LaserComb 2009, 12 Beam | Active comparator | Low Level Laser Medical Device 2009 with 12 laser beams Receives: Device: HairMax LaserComb |
| HairMax LaserComb 2009 9 Beam | Active comparator | Low Level Laser Mecial Device 2009 with 9 laser beams Receives: Device: HairMax LaserComb |
| Control device | Active comparator | The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants. Receives: Device: Control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Measured: baseline, 16 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zoe Draelos, MD, Principal investigator, High Point, NCDavid Goldberg, M.D., Principal investigator, Skin & LaserAbe Marcadis, M.D., Principal investigator, Palm Beach Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947219
- Sponsor's protocol ID
- 9.12 2009-M-02
- Status last verified
- Dec 2012
- First submitted
- 27 Jul 2009
- Last updated
- 31 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
PubMed 19366270
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
- ClinicalTrials.gov ID
- NCT00947219
- Acronym / sponsor ID
- 9.12 2009-M-02
- Conditions
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- Keywords
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Lexington International, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
Detailed description
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HairMax LaserComb 2009, 12 Beam | Active comparator | Device: HairMax LaserCombLow Level Laser Medical Device 2009 with 12 laser beams |
| HairMax LaserComb 2009 9 Beam | Active comparator | Device: HairMax LaserCombLow Level Laser Mecial Device 2009 with 9 laser beams |
| Control device | Active comparator | Device: Control deviceThe control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin Types I-IV
- Norwood-Hamilton IIa to V
- Active hair loss within last 12 months
Key exclusion criteria (2 listed)
- Photosensitivity to laser light
- Malignancy in the target area
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 |
|---|---|---|
| HairMax LaserCombDevice application 3 times week (non-consecutive days), for 26 weeks | Device | HairMax LaserComb 2009 9 Beam, HairMax LaserComb 2009, 12 Beam |
| Control deviceDevice is used 3 times a week on non-consecutive days | Device | Control device |
Primary outcome
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
Time frame: baseline, 16 and 26 weeks
The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19366270Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
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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.
Zoe Draelos, MD principal investigator
High Point, NC
David Goldberg, M.D. principal investigator
Skin & Laser
Abe Marcadis, M.D. principal investigator
Palm Beach Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HairMax LaserComb in people with Androgenetic Alopecia and Hair Loss, run by Lexington International, LLC 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 4 inclusion and 2 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 31 Jan 2013. 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. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia (time frame: baseline, 16 and 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 NCT00947219, 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 31 Jan 2013.