Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
This study has been completed.
Information provided by (Responsible Party):
First received: January 9, 2011
Last updated: September 6, 2016
Last verified: January 2014
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.
Device: LightSheer Duet
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece
Primary Outcome Measures:
- Hair Count [ Time Frame: 6 month following last treatment ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Experimental: HS treatment
Treatment with HS handpiece
Device: LightSheer Duet
LightSheer Duet HS handpiece
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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;
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282866
|Laser & Skin Surgery Medical Group Inc
|Sacramento, California, United States, 95816 |
ClinicalTrials.gov processed this record on December 08, 2016
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 9, 2011
|Results First Received:
||January 6, 2014
||September 6, 2016
||United States: Institutional Review Board