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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00981461
Other study ID # 151.0805
Secondary ID
Status Completed
Phase N/A
First received September 21, 2009
Last updated August 7, 2012
Start date October 2009
Est. completion date October 2010

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 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.


Description:

This is a randomized double-blind, control device clinical study across 5 sites, 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 assess at visit 4 (week 16).

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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 2010
Est. primary completion date October 2010
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
Device application 3 times week, for 26 weeks
Control Device
Device application 3 times week, for 26 weeks

Locations

Country Name City State
United States David Goldberg, MD Hackensack New Jersey
United States Janet Hickman, MD Lynchburg Virginia
United States Jose Mendez, DO Miami Florida
United States Sadick Research Group New York New York
United States Abe Marcadis, MD 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: 10.2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Terminal Hair Count Week 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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