Treatment of Androgenic Alopecia in Males
This study has been completed.
Sponsor:
Lexington International, LLC
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00947219
First received: July 27, 2009
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
| Condition | Intervention |
|---|---|
|
Androgenetic Alopecia Hair Loss Male Pattern Baldness |
Device: HairMax LaserComb Device: Control device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Lexington International, LLC:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 79 |
| Study Start Date: | July 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: HairMax LaserComb 2009, 12 Beam
Low Level Laser Medical Device 2009 with 12 laser beams
|
Device: HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
|
|
Active Comparator: HairMax LaserComb 2009 9 Beam
Low Level Laser Mecial Device 2009 with 9 laser beams
|
Device: HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
|
|
Active Comparator: Control device
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.
|
Device: Control device
Device is used 3 times a week on non-consecutive days
|
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.
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin Types I-IV
- Norwood-Hamilton IIa to V
- Active hair loss within last 12 months
Exclusion Criteria:
- Photosensitivity to laser light
- Malignancy in the target area
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947219
Locations
| United States, Florida | |
| Abe Marcadis, M.D. | |
| West Palm Beach, Florida, United States, 33409 | |
| United States, New Jersey | |
| David Goldberg, M.D. | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Zoe Draelos, M.D. | |
| High Point, North Carolina, United States, 27262 | |
Sponsors and Collaborators
Lexington International, LLC
Investigators
| Principal Investigator: | Zoe Draelos, MD | High Point, NC |
| Principal Investigator: | David Goldberg, M.D. | Skin & Laser |
| Principal Investigator: | Abe Marcadis, M.D. | Palm Beach Research |
More Information
Publications:
| Responsible Party: | Lexington International, LLC |
| ClinicalTrials.gov Identifier: | NCT00947219 History of Changes |
| Other Study ID Numbers: | 9.12 2009-M-02 |
| Study First Received: | July 27, 2009 |
| Results First Received: | January 6, 2011 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lexington International, LLC:
|
Androgenetic Alopecia Hair Loss Male Pattern Baldness |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013