Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-06 @ 11:52 AM
Study NCT ID:
NCT01801202
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
Sponsor:
Lumenis Be Ltd.
Organization:
Study Overview
Official Title:
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: