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Treatment of Androgenic Alopecia in Males

This study has been completed.
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014