Treatment of Androgenetic Alopecia in Females, 9 Beam

Androgenetic Alopecia Clinical Trial

Official title:

A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981461
• Other study ID #: 151.0805
• 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

Related Conditions & MeSH terms

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

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