NCT00947219

Brief Summary

The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 31, 2013

Completed
Last Updated

January 31, 2013

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

July 27, 2009

Results QC Date

January 6, 2011

Last Update Submit

December 21, 2012

Conditions

Androgenetic AlopeciaHair LossMale Pattern Baldness

Keywords

Androgenetic AlopeciaHair LossMale Pattern Baldness

Outcome Measures

Primary Outcomes (1)

  • Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia

    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.

    baseline, 16 and 26 weeks

Study Arms (3)

HairMax LaserComb 2009, 12 Beam

ACTIVE COMPARATOR

Low Level Laser Medical Device 2009 with 12 laser beams

Device: HairMax LaserComb

HairMax LaserComb 2009 9 Beam

ACTIVE COMPARATOR

Low Level Laser Mecial Device 2009 with 9 laser beams

Device: HairMax LaserComb

Control device

ACTIVE COMPARATOR

The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants.

Device: Control device

Interventions

HairMax LaserCombDEVICE

Device application 3 times week (non-consecutive days), for 26 weeks

HairMax LaserComb 2009 9 BeamHairMax LaserComb 2009, 12 Beam
Control deviceDEVICE

Device is used 3 times a week on non-consecutive days

Control device

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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 (3)

Abe Marcadis, M.D.

West Palm Beach, Florida, 33409, United States

Location

David Goldberg, M.D.

Hackensack, New Jersey, 07601, United States

Location

Zoe Draelos, M.D.

High Point, North Carolina, 27262, United States

Location

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

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
David Michaels
Organization
Lexington International, LLC
dm@hairmax.com
561-417-0200

Study Officials

  • Zoe Draelos, MD

    High Point, NC

    PRINCIPAL INVESTIGATOR

  • David Goldberg, M.D.

    Skin & Laser

    PRINCIPAL INVESTIGATOR

  • Abe Marcadis, M.D.

    Palm Beach Research

    PRINCIPAL INVESTIGATOR

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

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 31, 2013

Results First Posted

January 31, 2013

Record last verified: 2012-12

Locations

US(3)