NCT01437163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

September 18, 2011

Last Update Submit

July 11, 2016

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

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

    After 16 weeks of therapy

Study Arms (2)

Red Incandescent light source

SHAM COMPARATOR
Device: Laser and/or Light Hair Rejuvenation System

TopHat 655

ACTIVE COMPARATOR
Device: TopHat 655 rejuvenation system

Interventions

TopHat 655 rejuvenation systemDEVICE

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

TopHat 655
Laser and/or Light Hair Rejuvenation SystemDEVICE

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

Red Incandescent light source

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Adolfo Fernandez-Obregon, MD

Hoboken, New Jersey, 07030, United States

Location

Peter S. Halperin, MD

New York, New York, 10065, United States

Location

Raymond J. Lanzafame, MD

Rochester, New York, 14617, United States

Location

Jeffrey A. Sklar, MD

Woodbury, New York, 11797, United States

Location

Related Publications (2)

  • 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.

    PMID: 25124964DERIVED

  • 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.

    PMID: 24078483DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Raymond J. Lanzafame, MD

    Raymond J. Lanzafame, MD

    STUDY DIRECTOR

  • Peter S. Halperin, MD

    Peter S. Halperin, MD

    PRINCIPAL INVESTIGATOR

  • Adolfo Fernandez-Obregon, MD

    Adolfo Fernandez-Obregon, MD

    PRINCIPAL INVESTIGATOR

  • Jeffrey A Sklar, MD

    Center for Aesthetic Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2011

First Posted

September 20, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

US(4)