Hair RemovalNCT01801202
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
A study testing LightSheer Duet HS handpiece in people with Hair Removal, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction. Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hair Removal
- What is being tested?
- LightSheer Duet HS handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand and provide written Informed Consent;
- Healthy adult, male or female, 18 years of age or older with skin type I-IV;
- Having a suitable treatment area for hair removal;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
Who cannot join
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
- Uncontrolled systemic diseases such as diabetes;
- Active infections in the treated area;
Show all 25Show fewer
- Dysplastic nevi;
- Significant concurrent skin conditions or any inflammatory skin conditions;
- Active cold sores, open lacerations or abrasions;
- Chronic or cutaneous viral, fungal, or bacterial diseases;
- Current cancer;
- History of skin cancer or pre-cancerous lesions at the treatment areas;
- Use of Accutane™ (Isotretinoin) within the past six month;
- Keloid formation in the treatment area;
- Tattoos in the treatment area;
- Bleeding coagulopathies or use of anticoagulants;
- Auto-immune disorders;
- Erythema ab igne, when identified treatments should be discontinued;
- Photosensitivity disorder that can be exacerbated by laser or intense light;
- Herpes simplex in the treatment area;
- Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- Poor wound healing;
- Sunburns;
- Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;
- Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.
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 study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
- Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
- Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.
- Conditions
- Hair Removal
- Being tested
- LightSheer Duet HS handpiece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightSheer Duet HS handpieceDevice
The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).
| Study group | Role | What they receive |
|---|---|---|
| Hair removal | Experimental | hair removal treatment using 805nm LightSheer Duet HS handpiece Receives: Device: LightSheer Duet HS handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Events
To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece
Measured: 1 year
Hair count
To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece
Measured: 6 monts follow up
Secondary outcomes (2)
Subject's comfort using VAS
To evaluate subject's assessment of comfort associated with treatments
Measured: Baseline, 4, 8, 12, 16 weeks;
Asses subject's perception of improvement and satisfaction
To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire
Measured: 8, 16 weeks following baseline; 3 and 6 monts follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Kilmer, MD, Principal investigator, Laser & Skin Surgery Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801202
- Sponsor's protocol ID
- LUM-ABU-HS 805nm-12-01
- Status last verified
- Aug 2014
- First submitted
- 21 Feb 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
- ClinicalTrials.gov ID
- NCT01801202
- Acronym / sponsor ID
- LUM-ABU-HS 805nm-12-01
- Conditions
- Hair Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Feb 2013 (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 study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
- Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
- Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair removal | Experimental | Device: LightSheer Duet HS handpiecehair removal treatment using 805nm LightSheer Duet HS handpiece |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read, understand and provide written Informed Consent;
- Healthy adult, male or female, 18 years of age or older with skin type I-IV;
- Having a suitable treatment area for hair removal;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
Key exclusion criteria (25 listed)
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
- Uncontrolled systemic diseases such as diabetes;
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 Duet HS handpieceThe approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628). | Device | Hair removal |
Primary outcome
Number of subjects with Adverse Events
Time frame: 1 year
To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece
Hair count
Time frame: 6 monts follow up
To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece
2 secondary outcomes
Subject's comfort using VAS
Time frame: Baseline, 4, 8, 12, 16 weeks;
Asses subject's perception of improvement and satisfaction
Time frame: 8, 16 weeks following baseline; 3 and 6 monts follow up
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 29 Apr 2015.
Related trials for Hair Removal
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Recruiting
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Pilonidal Disease
Not yet recruiting
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Microbial Contamination, Environmental Contamination
Not yet recruiting
Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Androgenetic Alopecia, Cicatricial Alopecia
Not yet recruiting
Hair Regrowth Following Partial Thickness Removal of SSCIS
Squamous Cell Carcinoma (Skin), Squamous Cell Carcinoma in Situ
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.
Suzanne Kilmer, MD principal investigator
Laser & Skin Surgery Medical Group, Inc.
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 HS handpiece 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 25 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 29 Apr 2015. 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?
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?
Number of subjects with Adverse Events (time frame: 1 year). 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 29 Apr 2015.