Treatment of Androgenic Alopecia in Males

Androgenetic Alopecia Clinical Trial

Official title:

A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947219
• Other study ID #: 9.12 2009-M-02
• 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Hair Loss
• Male Pattern Baldness

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