We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Androgenic Alopecia in Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00947219
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Condition or disease Intervention/treatment
Androgenetic Alopecia Hair Loss Male Pattern Baldness Device: HairMax LaserComb Device: Control device

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 28, 2009    Key Record Dates
Results First Posted: January 31, 2013
Last Update Posted: January 31, 2013
Last Verified: December 2012

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