Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
This study has been completed.
Sponsor:
Lumenis Ltd.
Information provided by (Responsible Party):
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT01282866
First received: January 9, 2011
Last updated: February 17, 2013
Last verified: January 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hair Removal |
Device: LightSheer Duet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece |
Further study details as provided by Lumenis Ltd.:
Primary Outcome Measures:
- Hair count [ Time Frame: 6 month following last treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment time [ Time Frame: Each treatment ] [ Designated as safety issue: No ]
- Level of comfort associated with treatment [ Time Frame: Each treatment ] [ Designated as safety issue: No ]
- Hair count [ Time Frame: 15 month following last treatment ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HS treatment
Treatment with HS handpiece
|
Device: LightSheer Duet
LightSheer Duet HS handpiece
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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;
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Lumenis Ltd. |
| ClinicalTrials.gov Identifier: | NCT01282866 History of Changes |
| Other Study ID Numbers: | LUM- ABU-LSDuet-08-001 |
| Study First Received: | January 9, 2011 |
| Last Updated: | February 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 17, 2013