NCT00981461

Brief Summary

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia 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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

5 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

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 30, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

September 21, 2009

Results QC Date

April 12, 2012

Last Update Submit

August 7, 2012

Conditions

Androgenetic AlopeciaHair LossFemale Pattern Baldness

Keywords

Andregenetic AlopeciaHair LossFemale Pattern Baldness

Outcome Measures

Primary Outcomes (1)

  • Changes in Terminal Hair Count Week 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)

LLT Device 2009 9 Beam

ACTIVE COMPARATOR

HairMax LaserComb

Device: HairMax LaserComb

control device

SHAM COMPARATOR

control device

Device: Control Device

Interventions

HairMax LaserCombDEVICE

Device application 3 times week, for 26 weeks

LLT Device 2009 9 Beam
Control DeviceDEVICE

Device application 3 times week, for 26 weeks

control 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 (5)

Jose Mendez, DO

Miami, Florida, 33144, United States

Location

Abe Marcadis, MD

Palm Beach, Florida, United States

Location

David Goldberg, MD

Hackensack, New Jersey, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Janet Hickman, MD

Lynchburg, Virginia, 24501, 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: 19366270RESULT

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
5614170200

Study Officials

  • Michael Jarratt, M.D.

    DermaResearch, Inc.

    PRINCIPAL INVESTIGATOR

  • Abe Marcadis, M.D.

    Palm Beach Research Center

    PRINCIPAL INVESTIGATOR

  • David Goldberg, M.D.

    Hackensack, NJ

    PRINCIPAL INVESTIGATOR

  • Neil S Sadick, MD

    Sadick Research Group

    PRINCIPAL INVESTIGATOR

  • Jose Mendez, DO

    International Dermatology Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Janet Hickman, MD

    The Education and Researvh Foundation

    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

September 21, 2009

First Posted

September 22, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 10, 2012

Results First Posted

July 30, 2012

Record last verified: 2012-08

Locations

US(5)