Treatment of Androgenetic Alopecia in Males and Females (LLLT)
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ClinicalTrials.gov Identifier: NCT01437163 |
Recruitment Status :
Completed
First Posted : September 20, 2011
Last Update Posted : July 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Androgenetic Alopecia | Device: TopHat 655 rejuvenation system Device: Laser and/or Light Hair Rejuvenation System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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. |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count [ Time Frame: After 16 weeks of therapy ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437163
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 |
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 |
Responsible Party: | Apira Science, Inc. |
ClinicalTrials.gov Identifier: | NCT01437163 |
Other Study ID Numbers: |
ApiraTH655 |
First Posted: | September 20, 2011 Key Record Dates |
Last Update Posted: | July 12, 2016 |
Last Verified: | July 2016 |
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |