Treatment of Androgenetic Alopecia in Males and Females (LLLT)

Apira Science

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Device: TopHat 655 rejuvenation system; Device: Laser and/or Light Hair Rejuvenation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437163

ApiraTH655

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.

Enrollment: 88 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of androgenetic alopecia
• Fitzpatrick Skin Phototypes I-IV
• Norwood-Hamilton IIa to V for males and Ludwig I or II for females
• Active hair loss within the last 12 months
• Willingness to refrain from using all other hair growth products or treatments
• In overall general good health as determined by the physician investigator

Exclusion criteria

• Photosensitivity to laser light and non-laser LED light operating at 655nms.
• Malignancy in the target treatment area
• Other forms of alopecia of the head
• Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp
• Unwillingness to remove hair replacement products during the therapy sessions
• Using any medications deemed to inhibit hair growth as determined by the physician investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Red Incandescent light source

Sham Comparator group

Treatment:

Device: Laser and/or Light Hair Rejuvenation System

TopHat 655

Active Comparator group

Treatment:

Device: TopHat 655 rejuvenation system