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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 9, 2011 |
| Last Updated Date | February 17, 2013 |
| Start Date ICMJE | June 2009 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Hair count [ Time Frame: 6 month following last treatment ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01282866 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece |
| Official Title ICMJE | Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece |
| Brief 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. 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Hair Removal |
| Intervention ICMJE | Device: LightSheer Duet
LightSheer Duet HS handpiece |
| Study Arm (s) | Experimental: HS treatment
Treatment with HS handpiece
Intervention: Device: LightSheer Duet |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 35 |
| Completion Date | November 2011 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01282866 |
| Other Study ID Numbers ICMJE | LUM- ABU-LSDuet-08-001 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Lumenis Ltd. |
| Study Sponsor ICMJE | Lumenis Ltd. |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Lumenis Ltd. |
| Verification Date | January 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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