Androgenetic AlopeciaNCT01016964
Treatment of Androgenetic Alopecia in Females, 12 Beam
A study testing HairMax LaserComb 2009 model 12 beam 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 efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
- What is being tested?
- HairMax LaserComb 2009 model 12 beam
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Mar 2011
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin types I-IV
- Ludwig I-4, II-1, II-2, or frontal
- Active hair loss within last 12 months
Who cannot join
- Photosensitivity to laser light
- Malignancy in the target area
- Pregnancy
- Lactating females
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Foundation - Department of Dermatology
Cleveland, Ohio, 44195
University of Miami Miller School of Medicine - Dermatology
Miami, Florida, 33136
University of Minnesota, Department of Dermatology
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
Read the detailed description
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 63 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.
Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
- Conditions
- Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
- Being tested
- HairMax LaserComb 2009 model 12 beam, Sham Device
- Keywords
- Androgenetic Alopecia, Hair Loss, Female 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 LaserComb 2009 model 12 beamDevice
HairMax LaserComb
Sham DeviceDevice
Sham Device
| Study group | Role | What they receive |
|---|---|---|
| Sham Device | Sham comparator | Sham device Receives: Device: Sham Device |
| LLT Device 2009 12 Beams | Active comparator | HairMax LaserComb 2009 model 12 beam Receives: Device: HairMax LaserComb 2009 model 12 beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair Count at 16 and 26 Weeks Over Baseline
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 weeks, 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 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMar 2011
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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, M.D., Principal investigator, University of MinnesotaWilma Bergfeld, M.D., Principal investigator, The Cleveland ClinicLawrence Schachner, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016964
- Sponsor's protocol ID
- 12 2009-F-02
- Status last verified
- Aug 2012
- First submitted
- 18 Nov 2009
- Last updated
- 7 Sep 2012
- 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 7 Sep 2012. 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 HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females
- ClinicalTrials.gov ID
- NCT01016964
- Acronym / sponsor ID
- 12 2009-F-02
- Conditions
- Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
- Keywords
- Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Lexington International, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 7 Sep 2012
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 efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
Detailed description
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 63 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.
Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
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
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Device | Sham comparator | Device: Sham DeviceSham device |
| LLT Device 2009 12 Beams | Active comparator | Device: HairMax LaserComb 2009 model 12 beamHairMax LaserComb 2009 model 12 beam |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin types I-IV
- Ludwig I-4, II-1, II-2, or frontal
- Active hair loss within last 12 months
Key exclusion criteria (4 listed)
- Photosensitivity to laser light
- Malignancy in the target area
- Pregnancy
- Lactating females
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 LaserComb 2009 model 12 beamHairMax LaserComb | Device | LLT Device 2009 12 Beams |
| Sham DeviceSham Device | Device | Sham Device |
Primary outcome
Change in Hair Count at 16 and 26 Weeks Over Baseline
Time frame: Baseline, 16 weeks, 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 7 Sep 2012.
- 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.
Maria Hordinsky, M.D. principal investigator
University of Minnesota
Wilma Bergfeld, M.D. principal investigator
The Cleveland Clinic
Lawrence Schachner, M.D. principal investigator
University of Miami
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 2009 model 12 beam 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 4 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 7 Sep 2012. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2012). 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?
Change in Hair Count at 16 and 26 Weeks Over Baseline (time frame: Baseline, 16 weeks, 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 NCT01016964, 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 7 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.