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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01686841
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Zeltiq Aesthetics

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

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The Zeltiq System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : September 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Fat Reduction Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis

Primary Outcome Measures :
  1. 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.

  2. Safety: UADE [ Time Frame: 12 weeks post final treatment ]
    Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  1. Male subjects >18 years of age and <25 years of age.
  2. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
  3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
  4. Willingness to participate in the study
  5. Willingness to receive EXPERIMENTAL treatment
  6. Informed consent agreement signed by the subject
  7. Willingness to follow the treatment schedule and post treatment care requirements
  8. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment

Exclusion criteria

  1. Subject has a history of isotretinoin use
  2. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
  3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria
  4. Presence of suntan in the area to be treated
  5. Subject is immunosuppressed
  6. Subject is unable to comply with treatment, home care or follow-up visits
  7. Subject has a history of vitiligo
  8. Subject has a history of keloid formation
  9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  10. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01686841

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Zeltiq Aesthetics
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Principal Investigator: Rox Anderson, MD MGH
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Responsible Party: Zeltiq Aesthetics Identifier: NCT01686841    
Other Study ID Numbers: ZA12-003
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zeltiq Aesthetics:
Fat Reduction
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases