Treatment of Androgenetic Alopecia in Females, 12 Beam

Androgenetic Alopecia Clinical Trial

Official title:

A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016964
• Other study ID #: 12 2009-F-02
• 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

Related Conditions & MeSH terms

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

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