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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00947219
Other study ID # 9.12 2009-M-02
Secondary ID
Status Completed
Phase N/A
First received July 27, 2009
Last updated December 21, 2012
Start date July 2009
Est. completion date August 2010

Study information

Verified date December 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 change in terminal hair count at 16 and 26 weeks compared to baseline measurements.


Description:

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve approximately 75 male 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 Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

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

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


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria:

- Diagnosis of androgenetic alopecia

- Fitzpatrick Skin Types I-IV

- Norwood-Hamilton IIa to V

- Active hair loss within last 12 months

Exclusion Criteria:

- Photosensitivity to laser light

- Malignancy in the target area

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
Device application 3 times week (non-consecutive days), for 26 weeks
Control device
Device is used 3 times a week on non-consecutive days

Locations

Country Name City State
United States David Goldberg, M.D. Hackensack New Jersey
United States Zoe Draelos, M.D. High Point North Carolina
United States Abe Marcadis, M.D. West Palm Beach Florida

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 Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia 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 and 26 weeks No
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