NCT01016964

Brief Summary

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

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

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 7, 2012

Completed
Last Updated

September 7, 2012

Status Verified

August 1, 2012

Enrollment Period

1.2 years

First QC Date

November 18, 2009

Results QC Date

June 25, 2012

Last Update Submit

August 7, 2012

Conditions

Androgenetic AlopeciaHair LossFemale Pattern Baldness

Keywords

Androgenetic AlopeciaHair LossFemale Pattern Baldness

Outcome Measures

Primary Outcomes (1)

  • Change in Hair Count at 16 and 26 Weeks Over Baseline

    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 weeks, 26 weeks

Study Arms (2)

Sham Device

SHAM COMPARATOR

Sham device

Device: Sham Device

LLT Device 2009 12 Beams

ACTIVE COMPARATOR

HairMax LaserComb 2009 model 12 beam

Device: HairMax LaserComb 2009 model 12 beam

Interventions

HairMax LaserComb 2009 model 12 beamDEVICE

HairMax LaserComb

LLT Device 2009 12 Beams
Sham DeviceDEVICE

Sham Device

Sham Device

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Photosensitivity to laser light
  • Malignancy in the target area
  • Pregnancy
  • Lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami Miller School of Medicine - Dermatology

Miami, Florida, 33136, United States

Location

University of Minnesota, Department of Dermatology

Minneapolis, Minnesota, 55455, United States

Location

Cleveland Clinic Foundation - Department of Dermatology

Cleveland, Ohio, 44195, 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
las@hairmax.com
5614170200

Study Officials

  • Maria Hordinsky, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Wilma Bergfeld, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Lawrence Schachner, M.D.

    University of Miami

    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

November 18, 2009

First Posted

November 20, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 7, 2012

Results First Posted

September 7, 2012

Record last verified: 2012-08

Locations

US(3)