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| Sponsor: | Lexington International, LLC |
|---|---|
| Information provided by: | Lexington International, LLC |
| ClinicalTrials.gov Identifier: | NCT00947505 |
Purpose
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in men diagnosed with androgenetic alopecia when treatment is applied as directed.
| Condition | Intervention |
|---|---|
|
Androgenetic Alopecia Hair Loss Male Pattern Baldness |
Device: HairMax LaserComb |
| 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, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males |
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: LLT Device 2009 7 Beam |
Device: HairMax LaserComb
Device application 3 times week, for 26 weeks
Other Name: HairMax LaserComb
|
| Active Comparator: Control Device |
Device: HairMax LaserComb
Device application 3 times week, for 26 weeks
Other Name: HairMax LaserComb
|
This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve 45 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 nonconcurring days a week as directed per device for 26 weeks treatment 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.
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Abe Marcadis, M.D. | |
| Palm Beach, Florida, United States, 33409 | |
| United States, Texas | |
| Michael Jarratt, MD | |
| Austin, Texas, United States, 78759 | |
| Principal Investigator: | Michael Jarratt, M.D. | DermaResearch, Inc. |
| Principal Investigator: | Abe Marcadis, M.D. | Palm Beach Research Center |
More Information
| Responsible Party: | David Michaels, Managing Director, Lexington International, LLC |
| ClinicalTrials.gov Identifier: | NCT00947505 History of Changes |
| Other Study ID Numbers: | 7 2009-M-01 |
| Study First Received: | July 27, 2009 |
| Last Updated: | August 17, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Androgenetic alopecia Hair loss Male Pattern baldness |
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
