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Treatment of Androgenetic Alopecia in Females, 9 Beam

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: NCT00981461
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : July 30, 2012
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Hair Loss Female Pattern Baldness Device: HairMax LaserComb Device: Control Device Not Applicable

Detailed Description:

This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial with 60 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.

Initial efficacy endpoint for each subject will be assess at visit 4 (week 16).

Safety analysis will be assessed based on the reports of adverse events during study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LLT Device 2009 9 Beam
HairMax LaserComb
 Device: HairMax LaserComb
Device application 3 times week, for 26 weeks
Sham Comparator: control device
control device
 Device: Control Device
Device application 3 times week, for 26 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline [ Time Frame: Baseline, 16 weeks, 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
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of androgenetic alopecia
  • Fitzpatrick Skin Types I-IV
  • Ludwig I-4, II-1, II-2, or frontal
  • Active hair loss within last 12 months

Exclusion Criteria:

  • Photosensitivity to laser light
  • Malignancy in the target area
  • Pregnancy
  • Lactating females
Contacts and Locations
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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): NCT00981461


Locations
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United States, Florida
Jose Mendez, DO
Miami, Florida, United States, 33144
Abe Marcadis, MD
Palm Beach, Florida, United States
United States, New Jersey
David Goldberg, MD
Hackensack, New Jersey, United States
United States, New York
Sadick Research Group
New York, New York, United States, 10075
United States, Virginia
Janet Hickman, MD
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Lexington International, LLC
Investigators
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Principal Investigator: Michael Jarratt, M.D. DermaResearch, Inc.
Principal Investigator: Abe Marcadis, M.D. Palm Beach Research Center
Principal Investigator: David Goldberg, M.D. Hackensack, NJ
Principal Investigator: Neil S Sadick, MD Sadick Research Group
Principal Investigator: Jose Mendez, DO International Dermatology Research, Inc.
Principal Investigator: Janet Hickman, MD The Education and Researvh Foundation
More Information
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Publications of Results:

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Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00981461    
Other Study ID Numbers: 151.0805
First Posted: September 22, 2009    Key Record Dates
Results First Posted: July 30, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012
Keywords provided by Lexington International, LLC:
Andregenetic Alopecia
Hair Loss
Female Pattern Baldness
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical