Trial record 4 of 63 for:    "male pattern baldness" OR "Androgenetic Alopecia"

Treatment of Androgenetic Alopecia in Females, 9 Beam

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00981461
First received: September 21, 2009
Last updated: August 7, 2012
Last verified: August 2012
  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:


Further study details as provided by Lexington International, LLC:

Primary Outcome Measures:
  • Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline [ Time Frame: Baseline, 16 weeks, 26 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 72
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
HairMax LaserComb
Device: HairMax LaserComb
Device application 3 times week, for 26 weeks
Other Name: HairMax LaserComb
Sham Comparator: control device
control device
Device: Control Device
Device application 3 times week, for 26 weeks
Other Name: control device

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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:
Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00981461     History of Changes
Other Study ID Numbers: 151.0805
Study First Received: September 21, 2009
Results First Received: April 12, 2012
Last Updated: August 7, 2012
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 July 28, 2014