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Treatment of Androgenetic Alopecia in Females, 12 Beam

Primary Purpose

Androgenetic Alopecia, Hair Loss, Female Pattern Baldness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HairMax LaserComb 2009 model 12 beam
Sham Device
Sponsored by
Lexington International, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia, Hair Loss, Female Pattern Baldness

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine - Dermatology
  • University of Minnesota, Department of Dermatology
  • Cleveland Clinic Foundation - Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham Device

LLT Device 2009 12 Beams

Arm Description

Sham device

HairMax LaserComb 2009 model 12 beam

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2009
Last Updated
August 7, 2012
Sponsor
Lexington International, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01016964
Brief Title
Treatment of Androgenetic Alopecia in Females, 12 Beam
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexington International, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Hair Loss, Female Pattern Baldness
Keywords
Androgenetic Alopecia, Hair Loss, Female Pattern Baldness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Sham device
Arm Title
LLT Device 2009 12 Beams
Arm Type
Active Comparator
Arm Description
HairMax LaserComb 2009 model 12 beam
Intervention Type
Device
Intervention Name(s)
HairMax LaserComb 2009 model 12 beam
Intervention Description
HairMax LaserComb
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Sham Device
Primary Outcome Measure Information:
Title
Change in Hair Count at 16 and 26 Weeks Over Baseline
Description
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.
Time Frame
Baseline, 16 weeks, 26 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wilma Bergfeld, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Schachner, M.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine - Dermatology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Minnesota, Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cleveland Clinic Foundation - Department of Dermatology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19366270
Citation
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.
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Treatment of Androgenetic Alopecia in Females, 12 Beam

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