Treatment of Androgenetic Alopecia in Males
A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males
1 other identifier
interventional
49
1 country
2
Brief Summary
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
July 30, 2012
CompletedJuly 30, 2012
June 1, 2012
1 year
July 27, 2009
January 6, 2011
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
16 and 26 weeks
Study Arms (2)
HairMax LaserComb 2009, 7 Beam
ACTIVE COMPARATORLower level laser phototherapy medical device with 7 laser beams
Control Device
ACTIVE COMPARATORIdentical to the Active device, but with 7 LED's instead of lasers
Interventions
Device application 3 times week (non-consecutive days), for 26 weeks
Device application 3 times week (non-consecutive days), for 26 weeks
Eligibility Criteria
You may qualify if:
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin Types I-IV
- Norwood-Hamilton IIa to V
- Active hair loss within last 12 months
You may not qualify if:
- Photosensitivity to laser light
- Malignancy in the target area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Abe Marcadis, M.D.
Palm Beach, Florida, 33409, United States
Michael Jarratt, MD
Austin, Texas, 78759, United States
Related Publications (1)
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.
PMID: 19366270BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Michaels
- Organization
- Lexington International, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Jarratt, M.D.
DermaResearch, Inc.
- PRINCIPAL INVESTIGATOR
Abe Marcadis, M.D.
Palm Beach Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2009
First Posted
July 28, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
July 30, 2012
Results First Posted
July 30, 2012
Record last verified: 2012-06