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Treatment of Androgenetic Alopecia in Females, 9 Beam

NCT ID: NCT00981461

Last Updated: 2012-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial with 60 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.

Initial efficacy endpoint for each subject will be assess at visit 4 (week 16).

Safety analysis will be assessed based on the reports of adverse events during study.

Conditions

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Androgenetic Alopecia Hair Loss Female Pattern Baldness

Keywords

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Andregenetic Alopecia Hair Loss Female Pattern Baldness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LLT Device 2009 9 Beam

HairMax LaserComb

Group Type ACTIVE_COMPARATOR

HairMax LaserComb

Intervention Type DEVICE

Device application 3 times week, for 26 weeks

control device

control device

Group Type SHAM_COMPARATOR

Control Device

Intervention Type DEVICE

Device application 3 times week, for 26 weeks

Interventions

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HairMax LaserComb

Device application 3 times week, for 26 weeks

Intervention Type DEVICE

Control Device

Device application 3 times week, for 26 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Photosensitivity to laser light
* Malignancy in the target area
* Pregnancy
* Lactating females
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lexington International, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Jarratt, M.D.

Role: PRINCIPAL_INVESTIGATOR

DermaResearch, Inc.

Abe Marcadis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Palm Beach Research Center

David Goldberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hackensack, NJ

Neil S Sadick, MD

Role: PRINCIPAL_INVESTIGATOR

Sadick Research Group

Jose Mendez, DO

Role: PRINCIPAL_INVESTIGATOR

International Dermatology Research, Inc.

Janet Hickman, MD

Role: PRINCIPAL_INVESTIGATOR

The Education and Researvh Foundation

Locations

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Jose Mendez, DO

Miami, Florida, United States

Site Status

Abe Marcadis, MD

Palm Beach, Florida, United States

Site Status

David Goldberg, MD

Hackensack, New Jersey, United States

Site Status

Sadick Research Group

New York, New York, United States

Site Status

Janet Hickman, MD

Lynchburg, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19366270 (View on PubMed)

Other Identifiers

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151.0805

Identifier Type: -

Identifier Source: org_study_id