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

Study Overview
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Brief Summary
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To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.

Official Title
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PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The Zeltiq System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fat Reduction<br> | Device: The Zeltiq System<br>* Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>* Other names: Lipolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks post final treatment | 
| Safety: UADE | Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs. | 12 weeks post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: AE's | • Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects. | 12 weeks post final treatment | 
| Feasibility: Reduction of Sebum Production | • Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment. | 12 weeks post final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipolysis, Cryolipolysis, Fat Reduction