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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01437163
Other study ID # ApiraTH655
Secondary ID
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


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
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