Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sham Device
Sham device
Sham Device
Sham Device
LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
HairMax LaserComb 2009 model 12 beam
HairMax LaserComb
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HairMax LaserComb 2009 model 12 beam
HairMax LaserComb
Sham Device
Sham Device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fitzpatrick Skin types I-IV
* Ludwig I-4, II-1, II-2, or frontal
* Active hair loss within last 12 months
Exclusion Criteria
* Malignancy in the target area
* Pregnancy
* Lactating females
25 Years
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lexington International, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Hordinsky, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Wilma Bergfeld, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Lawrence Schachner, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Miller School of Medicine - Dermatology
Miami, Florida, United States
University of Minnesota, Department of Dermatology
Minneapolis, Minnesota, United States
Cleveland Clinic Foundation - Department of Dermatology
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12 2009-F-02
Identifier Type: -
Identifier Source: org_study_id
NCT01042756
Identifier Type: -
Identifier Source: nct_alias