Treatment of Androgenetic Alopecia in Males and Females

Androgenetic Alopecia Clinical Trial

— LLLT  

Official title:

The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437163
• Other study ID #: ApiraTH655
• Status: Completed
• Phase: N/A
• First received: September 18, 2011
• Last updated: July 11, 2016
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: July 2016
• Source: Apira Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• TopHat 655 rejuvenation system
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
• Laser and/or Light Hair Rejuvenation System
A red incandescent light source replaces all lasers and light emitting diodes.

Locations

Country	Name	City	State
United States	Adolfo Fernandez-Obregon, MD	Hoboken	New Jersey
United States	Peter S. Halperin, MD	New York	New York
United States	Raymond J. Lanzafame, MD	Rochester	New York
United States	Jeffrey A. Sklar, MD	Woodbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
Apira Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count		After 16 weeks of therapy	No