A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
|ClinicalTrials.gov Identifier: NCT01686841|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment|
|Body Fat Disorder||Device: The Zeltiq System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR|
|Actual Study Start Date :||September 2012|
|Primary Completion Date :||June 2017|
|Study Completion Date :||June 2017|
|Experimental: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
- Feasibility: Reduction of Sebum Production [ Time Frame: 12 weeks post final treatment ]• 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 ]Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
- Safety: AE's [ Time Frame: 12 weeks post final treatment ]• 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 ]• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686841
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Rox Anderson, MD||MGH|