Treatment of Androgenetic Alopecia in Females, 9 Beam - Full Text View

Sponsor:	Lexington International, LLC
Information provided by:	Lexington International, LLC
ClinicalTrials.gov Identifier:	NCT00981461

Purpose

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.

Condition	Intervention
Androgenetic Alopecia Hair Loss Female Pattern Baldness	Device: HairMax LaserComb Device: Control Device

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

U.S. FDA Resources

Further study details as provided by Lexington International, LLC:

Primary Outcome Measures:

Promotion of hair growth [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: LLT Device 2009 9 Beam	Device: HairMax LaserComb Device application 3 times week, for 26 weeks Other Name: HairMax LaserComb Device: Control Device Device application 3 times week, for 26 weeks
Active Comparator: control device	Device: Control Device Device application 3 times week, for 26 weeks

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.

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981461

Locations

United States, Florida
Jose Mendez, DO
Miami, Florida, United States, 33144
Abe Marcadis, MD
Palm Beach, Florida, United States
United States, New Jersey
David Goldberg, MD
Hackensack, New Jersey, United States
United States, New York
Sadick Research Group
New York, New York, United States, 10075
United States, Texas
Michael Jarratt, MD
Austin, Texas, United States
United States, Virginia
Janet Hickman, MD
Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Lexington International, LLC

Investigators

Principal Investigator:	Michael Jarratt, M.D.	DermaResearch, Inc.
Principal Investigator:	Abe Marcadis, M.D.	Palm Beach Research Center
Principal Investigator:	David Goldberg, M.D.	Hackensack, NJ
Principal Investigator:	Neil S Sadick, MD	Sadick Research Group
Principal Investigator:	Jose Mendez, DO	International Dermatology Research, Inc.
Principal Investigator:	Janet Hickman, MD	The Education and Researvh Foundation

More Information

Publications:

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.

Responsible Party:	David Michaels, Managing Direcctor, Lexington International, LLC
ClinicalTrials.gov Identifier:	NCT00981461 History of Changes
Other Study ID Numbers:	151.0805
Study First Received:	September 21, 2009
Last Updated:	October 15, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Lexington International, LLC:

Andregenetic Alopecia
Hair Loss
Female Pattern Baldness

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis

Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012