Treatment of Androgenetic Alopecia in Males and Females

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adolfo Fernandez-Obregon, MD, Hoboken, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TopHat 655 rejuvenation system

Device

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

Device

A red incandescent light source replaces all lasers and light emitting diodes.

Primary outcomes

Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count

Time frame: After 16 weeks of therapy

Sponsors and collaborators

Lead sponsor

Apira Science, Inc.

Industry

Registry information

Official study title

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

Acronym: LLLT

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 20, 2011
Registry last updated: Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed