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

This study has been completed.
Information provided by (Responsible Party):
Zeltiq Aesthetics Identifier:
First received: September 12, 2012
Last updated: June 20, 2017
Last verified: June 2017
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.

Condition Intervention
Body Fat Disorder Device: The Zeltiq System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other

Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 11
Actual Study Start Date: September 2012
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01686841

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Zeltiq Aesthetics
Principal Investigator: Rox Anderson, MD MGH
  More Information

Responsible Party: Zeltiq Aesthetics Identifier: NCT01686841     History of Changes
Other Study ID Numbers: ZA12-003
Study First Received: September 12, 2012
Last Updated: June 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zeltiq Aesthetics:
Fat Reduction

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on September 19, 2017