A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
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|ClinicalTrials.gov Identifier: NCT01686841|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The Zeltiq System||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2017|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|