Treatment of Androgenetic Alopecia in Males

• ClinicalTrials.gov Identifier: NCT00947505
• Recruitment Status: Completed
• First Posted: July 28, 2009
• Results First Posted: July 30, 2012
• Last Update Posted: July 30, 2012
• Sponsor: Lexington International, LLC
• Information provided by (Responsible Party): Lexington International, LLC

Tracking Information

• First Submitted Date: July 27, 2009
• First Posted Date: July 28, 2009
• Results First Submitted Date: January 6, 2011
• Results First Posted Date: July 30, 2012
• Last Update Posted Date: July 30, 2012
• Study Start Date: August 2009
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2012)

Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline [ Time Frame: 16 and 26 weeks ]

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

• Original Primary Outcome Measures (submitted: July 27, 2009): Promotion of hair growth [ Time Frame: 26 weeks/6 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Androgenetic Alopecia in Males
• Official Title: 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
• 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.

Detailed Description

This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve 45 male 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 Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

Subjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Androgenetic Alopecia
• Hair Loss
• Male Pattern Baldness

Intervention

• Device: HairMax LaserComb 2009, 7 Beam
  Device application 3 times week (non-consecutive days), for 26 weeks
  Other Name: HairMax LaserComb
• Device: HairMax LaserComb
  Device application 3 times week (non-consecutive days), for 26 weeks
  Other Name: Control device

Study Arms

• Active Comparator: HairMax LaserComb 2009, 7 Beam
  Lower level laser phototherapy medical device with 7 laser beams
  Intervention: Device: HairMax LaserComb 2009, 7 Beam
• Active Comparator: Control Device
  Identical to the Active device, but with 7 LED's instead of lasers
  Intervention: Device: HairMax LaserComb

• 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. doi: 10.2165/00044011-200929050-00001.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2012): 49
• Original Estimated Enrollment (submitted: July 27, 2009): 45
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of androgenetic alopecia
• Fitzpatrick Skin Types I-IV
• Norwood-Hamilton IIa to V
• Active hair loss within last 12 months

Exclusion Criteria:

• Photosensitivity to laser light
• Malignancy in the target area

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 25 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00947505
• Other Study ID Numbers: 7 2009-M-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lexington International, LLC
• Original Responsible Party: David Michaels, Managing Director, Lexington International, LLC
• Current Study Sponsor: Lexington International, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Jarratt, M.D.; DermaResearch, Inc.
• Principal Investigator: Abe Marcadis, M.D.; Palm Beach Research Center

• PRS Account: Lexington International, LLC
• Verification Date: June 2012