Treatment of Androgenetic Alopecia in Males and Females

NCT ID: NCT01437163

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Androgenetic Alopecia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Red Incandescent light source

Group Type SHAM_COMPARATOR

Laser and/or Light Hair Rejuvenation System

Intervention Type DEVICE

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

TopHat 655

Group Type ACTIVE_COMPARATOR

TopHat 655 rejuvenation system

Intervention Type DEVICE

TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TopHat 655 rejuvenation system

TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period

Intervention Type DEVICE

Laser and/or Light Hair Rejuvenation System

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Apira Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raymond J. Lanzafame, MD

Role: STUDY_DIRECTOR

Raymond J. Lanzafame, MD

Peter S. Halperin, MD

Role: PRINCIPAL_INVESTIGATOR

Peter S. Halperin, MD

Adolfo Fernandez-Obregon, MD

Role: PRINCIPAL_INVESTIGATOR

Adolfo Fernandez-Obregon, MD

Jeffrey A Sklar, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Aesthetic Dermatology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adolfo Fernandez-Obregon, MD

Hoboken, New Jersey, United States

Site Status

Peter S. Halperin, MD

New York, New York, United States

Site Status

Raymond J. Lanzafame, MD

Rochester, New York, United States

Site Status

Jeffrey A. Sklar, MD

Woodbury, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Lanzafame RJ, Blanche RR, Chiacchierini RP, Kazmirek ER, Sklar JA. The growth of human scalp hair in females using visible red light laser and LED sources. Lasers Surg Med. 2014 Oct;46(8):601-7. doi: 10.1002/lsm.22277. Epub 2014 Aug 13.

Reference Type DERIVED
PMID: 25124964 (View on PubMed)

Lanzafame RJ, Blanche RR, Bodian AB, Chiacchierini RP, Fernandez-Obregon A, Kazmirek ER. The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lasers Surg Med. 2013 Oct;45(8):487-95. doi: 10.1002/lsm.22173.

Reference Type DERIVED
PMID: 24078483 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ApiraTH655

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.