Treatment of Androgenetic Alopecia in Males

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00947505
First received: July 27, 2009
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.


Condition Intervention
Androgenetic Alopecia
Hair Loss
Male Pattern Baldness
Device: HairMax LaserComb 2009, 7 Beam
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

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 Over Baseline [ Time Frame: 16 and 26 weeks ] [ Designated as safety issue: No ]
    Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region


Enrollment: 49
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: HairMax LaserComb 2009, 7 Beam
Lower level laser phototherapy medical device with 7 laser beams
Device: HairMax LaserComb 2009, 7 Beam
Device application 3 times week (non-consecutive days), for 26 weeks
Other Name: HairMax LaserComb
Active Comparator: Control Device
Identical to the Active device, but with 7 LED's instead of lasers
Device: HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Other Name: Control device

Detailed Description:

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
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: NCT00947505

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
Sponsors and Collaborators
Lexington International, LLC
Investigators
Principal Investigator: Michael Jarratt, M.D. DermaResearch, Inc.
Principal Investigator: Abe Marcadis, M.D. Palm Beach Research Center
  More Information

Publications:
Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00947505     History of Changes
Other Study ID Numbers: 7 2009-M-01
Study First Received: July 27, 2009
Results First Received: January 6, 2011
Last Updated: June 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 July 23, 2014