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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

November 18, 2009
August 7, 2012
January 2010
March 2011   (final data collection date for primary outcome measure)
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.
Promotion of hair growth [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01016964 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Androgenetic Alopecia in Females, 12 Beam
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Androgenetic Alopecia
  • Hair Loss
  • Female Pattern Baldness
  • Device: HairMax LaserComb 2009 model 12 beam
    HairMax LaserComb
  • Device: Sham Device
    Sham Device
  • Sham Comparator: Sham Device
    Sham device
    Intervention: Device: Sham Device
  • Active Comparator: LLT Device 2009 12 Beams
    HairMax LaserComb 2009 model 12 beam
    Intervention: Device: HairMax LaserComb 2009 model 12 beam
Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Female
25 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016964
12 2009-F-02
Yes
Lexington International, LLC
Lexington International, LLC
Not Provided
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
Lexington International, LLC
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP