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Treatment of Androgenetic Alopecia in Females, 9 Beam

Primary Purpose

Androgenetic Alopecia, Hair Loss, Female Pattern Baldness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HairMax LaserComb
Control 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 Andregenetic 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

  • Jose Mendez, DO
  • Abe Marcadis, MD
  • David Goldberg, MD
  • Sadick Research Group
  • Janet Hickman, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

LLT Device 2009 9 Beam

control device

Arm Description

HairMax LaserComb

control device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2009
Last Updated
August 7, 2012
Sponsor
Lexington International, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00981461
Brief Title
Treatment of Androgenetic Alopecia in Females, 9 Beam
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (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 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed 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.

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
Andregenetic 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
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLT Device 2009 9 Beam
Arm Type
Active Comparator
Arm Description
HairMax LaserComb
Arm Title
control device
Arm Type
Sham Comparator
Arm Description
control device
Intervention Type
Device
Intervention Name(s)
HairMax LaserComb
Intervention Description
Device application 3 times week, for 26 weeks
Intervention Type
Device
Intervention Name(s)
Control Device
Intervention Description
Device application 3 times week, for 26 weeks
Primary Outcome Measure Information:
Title
Changes in Terminal Hair Count Week 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
Michael Jarratt, M.D.
Organizational Affiliation
DermaResearch, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abe Marcadis, M.D.
Organizational Affiliation
Palm Beach Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Goldberg, M.D.
Organizational Affiliation
Hackensack, NJ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil S Sadick, MD
Organizational Affiliation
Sadick Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Mendez, DO
Organizational Affiliation
International Dermatology Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Hickman, MD
Organizational Affiliation
The Education and Researvh Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Mendez, DO
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Abe Marcadis, MD
City
Palm Beach
State/Province
Florida
Country
United States
Facility Name
David Goldberg, MD
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Janet Hickman, MD
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
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.
Results Reference
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Treatment of Androgenetic Alopecia in Females, 9 Beam

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