Hair RemovalNCT01282866
Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
A study testing LightSheer Duet in people with Hair Removal, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Removal
- What is being tested?
- LightSheer Duet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2011
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult, female, 18 years of age or older with skin type I-IV;
- Having at least one suitable treatment area for hair removal with brown hair;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to read, understand and provide written Informed Consent.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.
Who cannot join
- Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- Use of oral isotretinoin (Accutane®) within 6 months
- Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- History of keloid formation or poor wound healing in a previously injured skin area;
- Significant skin conditions affecting treated area or inflammatory skin conditions;
- Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
Show all 20Show fewer
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- Having a history of bleeding disorder or taking anticoagulation medications before the washout period, per the package insert, and at the physician's discretion;
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated, personal history of melanoma;
- Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
- Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
- Tattoos in the treatment areas;
- Dysplastic nevi in the treatment areas;
- Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study;
- Allergy or history of an allergy to any topical anesthetic used;
- Pregnant, expectation of pregnancy, postpartum (<3 months) or nursing (<6 weeks);
- History of livedo reticularis, an autoimmune vascular disease;
- Hypersensitivity at the treatment site to any agents, solutions, or gel used in the treatment (applies to ET handpiece only), if no alternative exists;
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser & Skin Surgery Medical Group Inc
Sacramento, California, 95816
About this study
The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
- Conditions
- Hair Removal
- Being tested
- LightSheer Duet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightSheer DuetDevice
LightSheer Duet HS handpiece
| Study group | Role | What they receive |
|---|---|---|
| HS treatment | Experimental | Treatment with HS handpiece Receives: Device: LightSheer Duet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Count
The hair at the treatment area is counted at Baseline and 6 months following the last treatment.
Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.
Measured: 6 month following last treatment
Secondary outcomes (3)
Treatment Time
The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.
Measured: Each treatment
Level of Comfort Associated With Treatment
Measured: Each treatment
Hair Count
The hair at the treatment area is counted at Baseline and 15 months following the last treatment.
Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline.
Measured: 15 month following last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJun 2009
- Primary completionNov 2011
- Study completionNov 2011
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 Hair RemovalStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282866
- Sponsor's protocol ID
- LUM- ABU-LSDuet-08-001
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2011
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
- ClinicalTrials.gov ID
- NCT01282866
- Acronym / sponsor ID
- LUM- ABU-LSDuet-08-001
- Conditions
- Hair Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Posted 3 Apr 2014
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 clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS treatment | Experimental | Device: LightSheer DuetTreatment with HS handpiece |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult, female, 18 years of age or older with skin type I-IV;
- Having at least one suitable treatment area for hair removal with brown hair;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to read, understand and provide written Informed Consent.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to market preference test enrollment and throughout the course of the study treatment.
Key exclusion criteria (20 listed)
- Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- Use of oral isotretinoin (Accutane®) within 6 months
- Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- History of keloid formation or poor wound healing in a previously injured skin area;
- Significant skin conditions affecting treated area or inflammatory skin conditions;
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 |
|---|---|---|
| LightSheer DuetLightSheer Duet HS handpiece | Device | HS treatment |
Primary outcome
Hair Count
Time frame: 6 month following last treatment
The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline.
3 secondary outcomes
Treatment Time
Time frame: Each treatment
Level of Comfort Associated With Treatment
Time frame: Each treatment
Hair Count
Time frame: 15 month following last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LightSheer Duet in people with Hair Removal, run by Lumenis Be Ltd. 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 5 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: finished, as of the sponsor's last update on 21 Oct 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?
Yes. Results are posted in the registry (first posted 3 Apr 2014). 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?
Hair Count (time frame: 6 month following 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 21 Oct 2016.