Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01708447
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2012-10-15
Brief Title:
Feasibility Study Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy Treatment
Sponsor:
Ulthera Inc
Organization:
Merz North America Inc
Study Overview
Official Title:
Feasibility Study Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy Treatment
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This study will evaluate the efficacy of a lidocaine topical anesthetic numbing cream for reducing discomfort associated with Ultherapy treatment
Detailed Description:
All subjects will receive a full face and neck Ultherapy treatment Thirty 30 minutes prior to treatment a topical anesthetic numbing cream will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck in a randomized fashion The subject and investigator or sub-investigator performing Ultherapy treatment will be blinded to the side to which the topical anesthetic is applied Pain scores will be collected following treatment of each section of the face and neck on both sides Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity and overall lifting and tightening of skin
Study Oversight
Has Oversight DMC:
None
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?:
None