A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The Zeltiq System

• Registration Number: NCT01686841
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fat Reduction	The Zeltiq System	-

Primary Outcome Measures

Name	Time	Method
Safety: UADE	12 weeks post final treatment	Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
Feasibility: Reduction of Sebum Production	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.

Secondary Outcome Measures

Name	Time	Method
Safety: AE's	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	12 weeks post final treatment	• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States