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Treatment of Androgenetic Alopecia in Males and Females (LLLT)
This study has been completed.
Sponsor:
Apira Science, Inc.
Information provided by (Responsible Party):
Apira Science, Inc.
ClinicalTrials.gov Identifier:
NCT01437163
First received: September 18, 2011
Last updated: July 11, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Androgenetic Alopecia | Device: TopHat 655 rejuvenation system Device: Laser and/or Light Hair Rejuvenation System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources. |
Resource links provided by NLM:
Further study details as provided by Apira Science, Inc.:
Primary Outcome Measures:
- Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count [ Time Frame: After 16 weeks of therapy ]
| Enrollment: | 88 |
| Study Start Date: | September 2011 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: Red Incandescent light source |
Device: Laser and/or Light Hair Rejuvenation System
A red incandescent light source replaces all lasers and light emitting diodes.
|
| Active Comparator: TopHat 655 |
Device: TopHat 655 rejuvenation system
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437163
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437163
Locations
| United States, New Jersey | |
| Adolfo Fernandez-Obregon, MD | |
| Hoboken, New Jersey, United States, 07030 | |
| United States, New York | |
| Peter S. Halperin, MD | |
| New York, New York, United States, 10065 | |
| Raymond J. Lanzafame, MD | |
| Rochester, New York, United States, 14617 | |
| Jeffrey A. Sklar, MD | |
| Woodbury, New York, United States, 11797 | |
Sponsors and Collaborators
Apira Science, Inc.
Investigators
| Study Director: | Raymond J. Lanzafame, MD | Raymond J. Lanzafame, MD |
| Principal Investigator: | 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Apira Science, Inc. |
| ClinicalTrials.gov Identifier: | NCT01437163 History of Changes |
| Other Study ID Numbers: |
ApiraTH655 |
| Study First Received: | September 18, 2011 |
| Last Updated: | July 11, 2016 |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on July 27, 2017