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Treatment of Androgenetic Alopecia in Females, 12 Beam

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT01016964
First received: November 18, 2009
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.


Condition Intervention
Androgenetic Alopecia
Hair Loss
Female Pattern Baldness
 Device: HairMax LaserComb 2009 model 12 beam
Device: Sham 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 Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lexington International, LLC:

Primary Outcome Measures:
  • Change in Hair Count at 16 and 26 Weeks Over Baseline [ Time Frame: Baseline, 16 weeks, 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: 63
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham Device
Sham device
 Device: Sham Device
Sham Device
Active Comparator: LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
 Device: HairMax LaserComb 2009 model 12 beam
HairMax LaserComb

Detailed Description:

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

The trial with 63 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 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:   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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016964

Locations
United States, Florida
University of Miami Miller School of Medicine - Dermatology
Miami, Florida, United States, 33136
United States, Minnesota
University of Minnesota, Department of Dermatology
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland Clinic Foundation - Department of Dermatology
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Lexington International, LLC
Investigators
Principal Investigator: Maria Hordinsky, M.D. University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Wilma Bergfeld, M.D. The Cleveland Clinic
Principal Investigator: Lawrence Schachner, M.D. University of Miami
  More Information

Publications:

Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT01016964     History of Changes
Obsolete Identifiers: NCT01042756
Other Study ID Numbers: 12 2009-F-02
Study First Received: November 18, 2009
Results First Received: June 25, 2012
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lexington International, LLC:
Androgenetic Alopecia
Hair Loss
Female Pattern Baldness

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013