Androgenetic AlopeciaNCT00981461
Treatment of Androgenetic Alopecia in Females, 9 Beam
A study testing HairMax LaserComb in people with Androgenetic Alopecia and Hair Loss, run by Lexington International, LLC at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2009to Oct 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
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
David Goldberg, MD
Hackensack, New Jersey
Janet Hickman, MD
Lynchburg, Virginia, 24501
Jose Mendez, DO
Miami, Florida, 33144
Sadick Research Group
New York, New York, 10075
Abe Marcadis, MD
Palm Beach, Florida
About this study
Official title: A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 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 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
Read the detailed description
This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 60 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 assess 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, Control Device
- Keywords
- Andregenetic 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 LaserCombDevice
Device application 3 times week, for 26 weeks
Control DeviceDevice
Device application 3 times week, for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| LLT Device 2009 9 Beam | Active comparator | HairMax LaserComb Receives: Device: HairMax LaserComb |
| control device | Sham comparator | control device 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 Week 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 posted22 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Jarratt, M.D., Principal investigator, DermaResearch, Inc.Abe Marcadis, M.D., Principal investigator, Palm Beach Research CenterDavid Goldberg, M.D., Principal investigator, Hackensack, NJNeil S Sadick, MD, Principal investigator, Sadick Research GroupJose Mendez, DO, Principal investigator, International Dermatology Research, Inc.Janet Hickman, MD, Principal investigator, The Education and Researvh Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981461
- Sponsor's protocol ID
- 151.0805
- Status last verified
- Aug 2012
- First submitted
- 21 Sep 2009
- Last updated
- 10 Aug 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 10 Aug 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, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females
- ClinicalTrials.gov ID
- NCT00981461
- Acronym / sponsor ID
- 151.0805
- Conditions
- Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
- Keywords
- Andregenetic Alopecia, Hair Loss, Female Pattern Baldness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Lexington International, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 30 Jul 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 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed description
This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 60 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 assess 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 |
|---|---|---|
| LLT Device 2009 9 Beam | Active comparator | Device: HairMax LaserCombHairMax LaserComb |
| control device | Sham comparator | Device: Control Devicecontrol device |
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 LaserCombDevice application 3 times week, for 26 weeks | Device | LLT Device 2009 9 Beam |
| Control DeviceDevice application 3 times week, for 26 weeks | Device | control device |
Primary outcome
Changes in Terminal Hair Count Week 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 10 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
Michael Jarratt, M.D. principal investigator
DermaResearch, Inc.
Abe Marcadis, M.D. principal investigator
Palm Beach Research Center
David Goldberg, M.D. principal investigator
Hackensack, NJ
5 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 5 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 Jul 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?
Changes in Terminal Hair Count Week 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 NCT00981461, 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 10 Aug 2012.