Back to resultsA Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Zeltiq System
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder focused on measuring Lipolysis, Cryolipolysis, Fat Reduction
Eligibility Criteria
Inclusion criteria
- Male subjects >18 years of age and <25 years of age.
- Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
- Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
- Willingness to participate in the study
- Willingness to receive EXPERIMENTAL treatment
- Informed consent agreement signed by the subject
- Willingness to follow the treatment schedule and post treatment care requirements
- Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment
Exclusion criteria
- Subject has a history of isotretinoin use
- Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
- Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria
- Presence of suntan in the area to be treated
- Subject is immunosuppressed
- Subject is unable to comply with treatment, home care or follow-up visits
- Subject has a history of vitiligo
- Subject has a history of keloid formation
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fat Reduction
Arm Description
Outcomes
Primary Outcome Measures
Feasibility: Reduction of Sebum Production
• 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
Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
Secondary Outcome Measures
Safety: AE's
• Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.
Feasibility: Reduction of Sebum Production
• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01686841
Brief Title
A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Official Title
PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fat Reduction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The Zeltiq System
Other Intervention Name(s)
Cryolipolysis, Lipolysis
Intervention Description
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Feasibility: Reduction of Sebum Production
Description
• 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.
Time Frame
12 weeks post final treatment
Title
Safety: UADE
Description
Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.
Time Frame
12 weeks post final treatment
Secondary Outcome Measure Information:
Title
Safety: AE's
Description
• Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.
Time Frame
12 weeks post final treatment
Title
Feasibility: Reduction of Sebum Production
Description
• Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.
Time Frame
12 weeks post final treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Male subjects >18 years of age and <25 years of age.
Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
Willingness to participate in the study
Willingness to receive EXPERIMENTAL treatment
Informed consent agreement signed by the subject
Willingness to follow the treatment schedule and post treatment care requirements
Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment
Exclusion criteria
Subject has a history of isotretinoin use
Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria
Presence of suntan in the area to be treated
Subject is immunosuppressed
Subject is unable to comply with treatment, home care or follow-up visits
Subject has a history of vitiligo
Subject has a history of keloid formation
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rox Anderson, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
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