Treatment of Androgenetic Alopecia in Males and Females

Not Applicable

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Device: TopHat 655 rejuvenation system; Device: Laser and/or Light Hair Rejuvenation System

• Registration Number: NCT01437163
• Lead Sponsor: Apira Science, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TopHat 655	TopHat 655 rejuvenation system	-
Red Incandescent light source	Laser and/or Light Hair Rejuvenation System	-

Primary Outcome Measures

Name	Time	Method
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count	After 16 weeks of therapy

Trial Locations

Locations (4)

Adolfo Fernandez-Obregon, MD; 🇺🇸 Hoboken, New Jersey, United States

Jeffrey A. Sklar, MD; 🇺🇸 Woodbury, New York, United States

Raymond J. Lanzafame, MD; 🇺🇸 Rochester, New York, United States

Peter S. Halperin, MD; 🇺🇸 New York, New York, United States