A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
This study is currently recruiting participants.
Verified September 2012 by Zeltiq Aesthetics
Information provided by (Responsible Party):
First received: September 12, 2012
Last updated: March 26, 2013
Last verified: September 2012
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR|
Further study details as provided by Zeltiq Aesthetics:
Primary Outcome Measures:
- Feasibility: Reduction of Sebum Production [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]• Reduction of sebum production as measured by the sebumeter at 2 weeks post-treatment. A 30% reduction of sebum production in any study cohort will be considered clinically meaningful.
- Safety: UADE [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
Secondary Outcome Measures:
- Safety: AE's [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]• Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.
- Feasibility: Reduction of Sebum Production [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686841
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: H. Ray Jalian, MD 617-643-6211 email@example.com|
|Principal Investigator: R. Rox Anderson, MD|
Sponsors and Collaborators