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Treatment of Androgenetic Alopecia in Males and Females (LLLT)

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TopHat 655 rejuvenation system
Laser and/or Light Hair Rejuvenation System
Sponsored by
Apira Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Adolfo Fernandez-Obregon, MD
  • Peter S. Halperin, MD
  • Raymond J. Lanzafame, MD
  • Jeffrey A. Sklar, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Red Incandescent light source

TopHat 655

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2011
Last Updated
July 11, 2016
Sponsor
Apira Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01437163
Brief Title
Treatment of Androgenetic Alopecia in Males and Females
Acronym
LLLT
Official Title
The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apira Science, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red Incandescent light source
Arm Type
Sham Comparator
Arm Title
TopHat 655
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TopHat 655 rejuvenation system
Intervention Description
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
Intervention Type
Device
Intervention Name(s)
Laser and/or Light Hair Rejuvenation System
Intervention Description
A red incandescent light source replaces all lasers and light emitting diodes.
Primary Outcome Measure Information:
Title
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
Time Frame
After 16 weeks of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond J. Lanzafame, MD
Organizational Affiliation
Raymond J. Lanzafame, MD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter S. Halperin, MD
Organizational Affiliation
Peter S. Halperin, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adolfo Fernandez-Obregon, MD
Organizational Affiliation
Adolfo Fernandez-Obregon, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey A Sklar, MD
Organizational Affiliation
Center for Aesthetic Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adolfo Fernandez-Obregon, MD
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Peter S. Halperin, MD
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Raymond J. Lanzafame, MD
City
Rochester
State/Province
New York
ZIP/Postal Code
14617
Country
United States
Facility Name
Jeffrey A. Sklar, MD
City
Woodbury
State/Province
New York
ZIP/Postal Code
11797
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25124964
Citation
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.
Results Reference
derived
PubMed Identifier
24078483
Citation
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. Erratum In: Lasers Surg Med. 2014 Apr;46(4):373.
Results Reference
derived

Learn more about this trial

Treatment of Androgenetic Alopecia in Males and Females

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