Androgenetic AlopeciaLLLTNCT01437163
Treatment of Androgenetic Alopecia in Males and Females
A study testing TopHat 655 rejuvenation system and Laser and/or Light Hair Rejuvenation System in people with Androgenetic Alopecia, run by Apira Science, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- TopHat 655 rejuvenation system and Laser and/or Light Hair Rejuvenation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Adolfo Fernandez-Obregon, MD
Hoboken, New Jersey, 07030
Peter S. Halperin, MD
New York, New York, 10065
Raymond J. Lanzafame, MD
Rochester, New York, 14617
Jeffrey A. Sklar, MD
Woodbury, New York, 11797
About this study
Official title: The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- TopHat 655 rejuvenation system, Laser and/or Light Hair Rejuvenation System
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopHat 655 rejuvenation systemDevice
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 SystemDevice
A red incandescent light source replaces all lasers and light emitting diodes.
| Study group | Role | What they receive |
|---|---|---|
| Red Incandescent light source | Sham comparator | Not described Receives: Device: Laser and/or Light Hair Rejuvenation System |
| TopHat 655 | Active comparator | Not described Receives: Device: TopHat 655 rejuvenation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
Measured: After 16 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apira Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond J. Lanzafame, MD, Study director, Raymond J. Lanzafame, MDPeter S. Halperin, MD, Principal investigator, Peter S. Halperin, MDAdolfo Fernandez-Obregon, MD, Principal investigator, Adolfo Fernandez-Obregon, MDJeffrey A Sklar, MD, Principal investigator, Center for Aesthetic Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437163
- Sponsor's protocol ID
- ApiraTH655
- Acronym
- LLLT
- Status last verified
- Jul 2016
- First submitted
- 18 Sep 2011
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25124964Lanzafame 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.
PubMed 24078483
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.
- ClinicalTrials.gov ID
- NCT01437163
- Acronym / sponsor ID
- LLLT / ApiraTH655
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Apira Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Incandescent light source | Sham comparator | Device: Laser and/or Light Hair Rejuvenation System |
| TopHat 655 | Active comparator | Device: TopHat 655 rejuvenation system |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopHat 655 rejuvenation systemTopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period | Device | TopHat 655 |
| Laser and/or Light Hair Rejuvenation SystemA red incandescent light source replaces all lasers and light emitting diodes. | Device | Red Incandescent light source |
Primary outcome
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
Time frame: After 16 weeks of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Derived from this study: PubMed 25124964Lanzafame 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.
- Derived from this study: PubMed 24078483Lanzafame 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond J. Lanzafame, MD study director
Raymond J. Lanzafame, MD
Peter S. Halperin, MD principal investigator
Peter S. Halperin, MD
Adolfo Fernandez-Obregon, MD principal investigator
Adolfo Fernandez-Obregon, MD
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TopHat 655 rejuvenation system and Laser and/or Light Hair Rejuvenation System in people with Androgenetic Alopecia, run by Apira Science, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count (time frame: After 16 weeks of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437163, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.