Excess Hair GrowthNCT02465788
Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction
A study testing GentleTouch in people with Excess Hair Growth, run by Syneron Medical at 1 site in United States.
Trial summary
The objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Excess Hair Growth
- What is being tested?
- GentleTouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is not pregnant and does not plan to become pregnant during their 16 month study period
- Subject has a minimum terminal hair density of 15 black or brown hairs in all 3cm x 3cm hair count evaluation areas. To distinguish terminal hair from vellus hair: terminal hairs are thicker, longer, and darker compared to vellus hairs which are short, fine and lightly color
- Subject is willing to have 5cm x 5cm square patches of reduced hair on all treatment areas for some time during and after the study period, perhaps even permanently
- Subject is willing to participate in the study
- Subject is willing to avoid sun exposure and tanning of the treatment areas for a time spanning two weeks before the first treatment to two weeks after the last treatments
- Subject has the ability to adhere to post treatment care requirements.
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- Subject can commit to follow-up schedule
- Subject is willing to have photographs taken of the treated area which will be used de-identified in evaluations and may be used de-identified in presentations and/or publications
- Subject can read and comprehend English
- Subject has completed the Informed Consent Form (ICF)
Who cannot join
- Subject has only white, red, blond or grey hairs in the treatment areas
- Subject has injury, scarring or infection in the treatment areas
- Subject has a tattoo in the treatment areas
- Subject is pregnant or is lactating or plans to become pregnant during their 16 month study period. Pregnancy will be assessed by question at screening
- Subject is not willing to have long term hair loss in the treated areas
- Subject is not willing to discontinue shaving treatment areas at least one week prior to treatment and follow-up visits
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- Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc
- Subject is photosensitive due to having a condition such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
- Subject has used Accutane or other oral retinoic acid therapy in the past 6 months
- Subject has a known anticoagulation or thromboembolic condition
- Subject is taking anticoagulation medication
- Subject has a known history of hypertrophic or keloid scars following skin injury
- Subject has known collagen vascular disease such as scleroderma, lupus, etc
- Subject is immunocompromised (including HIV infection or AIDS) or currently using immunosuppressive medications
- Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months
- Subject had electrolysis treatment over the treatment areas
- Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment areas
- Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated
- Subject has participated in a study of another device or drug within 1 month prior to enrollment or during this study
- Subject has allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians Laser & Dermatology Institute, LLC
Chicago, Illinois, 60611
About this study
Official title: LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES
The objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair reduction.
Read the detailed description
The study device (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. The laser can deliver 0.25 to 100 ms laser pulses at a maximum of 20 J/cm2. Bipolar RF energy will be delivered across the laser beam via two appropriately sized electrodes and spacing between the electrodes. Bipolar RF energy may be delivered at a maximum of 35 J operating at 1 MHz. Typical RF pulses will be of duration of between 100 and 300ms. Epidermal cooling is accomplished via contact with a cooled window.
- Conditions
- Excess Hair Growth
- Being tested
- GentleTouch
- Keywords
- Helos, Hair Removal, Hair Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleTouchDevice
Also called 755nm alexandrite laser energy with bipolar RF, Helos
Four distinct areas on each selected anatomical area will be treated with different treatment parameters.
| Study group | Role | What they receive |
|---|---|---|
| 755nm alexandrite laser with bipolar RF | Experimental | GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. Receives: Device: GentleTouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment
The primary efficacy endpoint is to measure the average percentage of hair reduction at 3 months post last treatment computed over all subjects and all treatment sites. Hair reduction will be evaluated by counting the number of terminal hairs present in the 3 cm by 3 cm defined region by at least two independent blinded trained reviewers of photos taken at baseline and at the follow-up visits.
Measured: Baseline, 3 months after last treatment
Secondary outcomes (1)
Average hair reduction for each anatomical site
Measured: 6-12 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excess Hair GrowthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, Study director, Syneron Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465788
- Sponsor's protocol ID
- IH141302
- Status last verified
- May 2016
- First submitted
- 28 May 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES
- ClinicalTrials.gov ID
- NCT02465788
- Acronym / sponsor ID
- IH141302
- Conditions
- Excess Hair Growth
- Keywords
- Helos, Hair Removal, Hair Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Jun 2015 (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 objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair reduction.
Detailed description
The study device (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. The laser can deliver 0.25 to 100 ms laser pulses at a maximum of 20 J/cm2. Bipolar RF energy will be delivered across the laser beam via two appropriately sized electrodes and spacing between the electrodes. Bipolar RF energy may be delivered at a maximum of 35 J operating at 1 MHz. Typical RF pulses will be of duration of between 100 and 300ms. Epidermal cooling is accomplished via contact with a cooled window.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 755nm alexandrite laser with bipolar RF | Experimental | Device: GentleTouchGentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is not pregnant and does not plan to become pregnant during their 16 month study period
- Subject has a minimum terminal hair density of 15 black or brown hairs in all 3cm x 3cm hair count evaluation areas. To distinguish terminal hair from vellus hair: terminal hairs are thicker, longer, and darker compared to vellus hairs which are short, fine and lightly color
- Subject is willing to have 5cm x 5cm square patches of reduced hair on all treatment areas for some time during and after the study period, perhaps even permanently
- Subject is willing to participate in the study
- Subject is willing to avoid sun exposure and tanning of the treatment areas for a time spanning two weeks before the first treatment to two weeks after the last treatments
Key exclusion criteria (20 listed)
- Subject has only white, red, blond or grey hairs in the treatment areas
- Subject has injury, scarring or infection in the treatment areas
- Subject has a tattoo in the treatment areas
- Subject is pregnant or is lactating or plans to become pregnant during their 16 month study period. Pregnancy will be assessed by question at screening
- Subject is not willing to have long term hair loss in the treated areas
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 |
|---|---|---|
| GentleTouchAlso: 755nm alexandrite laser energy with bipolar RF, HelosFour distinct areas on each selected anatomical area will be treated with different treatment parameters. | Device | 755nm alexandrite laser with bipolar RF |
Primary outcome
Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment
Time frame: Baseline, 3 months after last treatment
The primary efficacy endpoint is to measure the average percentage of hair reduction at 3 months post last treatment computed over all subjects and all treatment sites. Hair reduction will be evaluated by counting the number of terminal hairs present in the 3 cm by 3 cm defined region by at least two independent blinded trained reviewers of photos taken at baseline and at the follow-up visits.
1 secondary outcome
Average hair reduction for each anatomical site
Time frame: 6-12 months after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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.
Shlomit Mann study director
Syneron Medical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleTouch in people with Excess Hair Growth, run by Syneron Medical at 1 site 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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment (time frame: Baseline, 3 months after last treatment). 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 24 May 2016.