Treatment of Androgenetic Alopecia in Females, 12 Beam

Lexington International

Status: Completed

Conditions: Hair Loss; Female Pattern Baldness; Androgenetic Alopecia

Treatments: Device: Sham Device; Device: HairMax LaserComb 2009 model 12 beam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016964

12 2009-F-02

Details and patient eligibility

About

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.

Full description

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

The trial with 63 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 assessed at visit 4 (week 16).

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

Enrollment: 63 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

63 participants in 2 patient groups

Sham Device

Sham Comparator group

Description:

Sham device

Treatment:

Device: Sham Device

LLT Device 2009 12 Beams

Active Comparator group

Description:

HairMax LaserComb 2009 model 12 beam

Treatment:

Device: HairMax LaserComb 2009 model 12 beam