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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Zeltiq Aesthetics.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01686841
First received: September 12, 2012
Last updated: March 26, 2013
Last verified: September 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Feasibility: Reduction of Sebum Production [ Time Frame: 12 weeks post final treatment ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • Reduction of sebum production as measured by the sebumeter at 72 hours, 1 week, and 4 weeks post-treatment.


Estimated Enrollment: 28
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686841

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: H. Ray Jalian, MD    617-643-6211    hjalian@partners.org   
Principal Investigator: R. Rox Anderson, MD         
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01686841     History of Changes
Other Study ID Numbers: ZA12-003
Study First Received: September 12, 2012
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014