Treatment of Androgenetic Alopecia in Males

Lexington International

Status: Completed

Conditions: Hair Loss; Male Pattern Baldness; Androgenetic Alopecia

Treatments: Device: HairMax LaserComb; Device: HairMax LaserComb 2009, 7 Beam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00947505

7 2009-M-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Male

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups

HairMax LaserComb 2009, 7 Beam

Active Comparator group

Description:

Lower level laser phototherapy medical device with 7 laser beams

Treatment:

Device: HairMax LaserComb 2009, 7 Beam

Control Device

Active Comparator group

Description:

Identical to the Active device, but with 7 LED's instead of lasers

Treatment:

Device: HairMax LaserComb