Treatment of Androgenetic Alopecia in Males and Females
NCT ID: NCT01437163
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2011-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Red Incandescent light source
Laser and/or Light Hair Rejuvenation System
A red incandescent light source replaces all lasers and light emitting diodes.
TopHat 655
TopHat 655 rejuvenation system
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Apira Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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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
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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, United States
Countries
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References
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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.
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.
Other Identifiers
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ApiraTH655
Identifier Type: -
Identifier Source: org_study_id
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