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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01016964
Other study ID # 12 2009-F-02
Secondary ID
Status Completed
Phase N/A
First received November 18, 2009
Last updated August 7, 2012
Start date January 2010
Est. completion date March 2011

Study information

Verified date August 2012
Source Lexington International, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Other known NCT identifiers
  • NCT01042756

Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
United States Cleveland Clinic Foundation - Department of Dermatology Cleveland Ohio
United States University of Miami Miller School of Medicine - Dermatology Miami Florida
United States University of Minnesota, Department of Dermatology Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Lexington International, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.2165/00044011-200929050-00001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hair Count at 16 and 26 Weeks Over Baseline 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. Baseline, 16 weeks, 26 weeks No
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