Androgenetic AlopeciaNCT01967277
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
A study testing Handi-Dome Laser and Incandescent red light source. in people with Androgenetic Alopecia, run by Capillus, LLC at 2 sites in United States.
Trial summary
This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Handi-Dome Laser and Incandescent red light source.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -
Who cannot join
- Photosensitivity to the specific wavelength of light - 650 nanometers. 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 affects the scalp.
- In willingness to remove hair replacement products during the 16 weeks of therapy.
- Using any medications deemed to inhibit hair growth as determined by the physician investigator.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bodian Dermatology
Great Neck, New York, 11021
Center for Aesthetic Dermatology
Woodbury, New York, 11797
About this study
This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.
Read the detailed description
The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.
- Conditions
- Androgenetic Alopecia
- Being tested
- Handi-Dome Laser, Incandescent red light source.
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handi-Dome LaserDevice
One, 30 minute treatment, every other day for 16 weeks.
Incandescent red light source.Device
One, 30 minute treatment, every other day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Incandescent red light source | Placebo comparator | A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. Receives: Device: Incandescent red light source. |
| Handi-Dome Laser | Active comparator | Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. Receives: Device: Handi-Dome Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Measured: baseline and 17 weeks
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Measured: baseline and 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capillus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond R. Blanche, BA, Study director, NST Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967277
- Sponsor's protocol ID
- USC650
- Status last verified
- May 2015
- First submitted
- 18 Oct 2013
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
- ClinicalTrials.gov ID
- NCT01967277
- Acronym / sponsor ID
- USC650
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Capillus, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 6 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.
Detailed description
The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.
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 |
|---|---|---|
| Incandescent red light source | Placebo comparator | Device: Incandescent red light source.A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. |
| Handi-Dome Laser | Active comparator | Device: Handi-Dome LaserStudy subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -
Key exclusion criteria (4 listed)
- Photosensitivity to the specific wavelength of light - 650 nanometers. 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 affects the scalp.
- In willingness to remove hair replacement products during the 16 weeks of therapy.
- Using any medications deemed to inhibit hair growth as determined by the physician investigator.
- -
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 |
|---|---|---|
| Handi-Dome LaserOne, 30 minute treatment, every other day for 16 weeks. | Device | Handi-Dome Laser |
| Incandescent red light source.One, 30 minute treatment, every other day for 16 weeks. | Device | Incandescent red light source |
Primary outcome
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Time frame: baseline and 17 weeks
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Time frame: baseline and 17 weeks
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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 R. Blanche, BA study director
NST Consulting, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handi-Dome Laser and Incandescent red light source. in people with Androgenetic Alopecia, run by Capillus, LLC at 2 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 1 inclusion and 4 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 6 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. (time frame: baseline and 17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2015.