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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2010

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 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 assessed at visit 4 (week 16).

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

Intervention(s) in this Clinical Trial

• Device: HairMax LaserComb 2009 model 12 beam
  • HairMax LaserComb
• Device: Sham Device
  • Sham Device

Arms, Groups and Cohorts in this Clinical Trial

• Sham Comparator: Sham Device
  • Sham device
• Active Comparator: LLT Device 2009 12 Beams
  • HairMax LaserComb 2009 model 12 beam

Primary Measures

• Promotion of hair growth
  • Time Frame: 26 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Lexington International, LLC

Overall Clinical Trial Officials and Contacts

Maria Hordinsky, M.D. Principal Investigator University of Minnesota - Clinical and Translational Science Institute  

Overall Contact: Arthur Simon, PhD 561-689-0606 asimon@palmbeachcro.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016964

Study ID Number: 12 2009-F-02

ClinicalTrials.gov Identifier: NCT01016964

Health Authority: United States: Institutional Review Board