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

Body Fat Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686841
• Other study ID #: ZA12-003
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: June 20, 2017
• Start date: September 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety: UADE	Frequency of unanticipated adverse device effects (UADEs). Acceptance criteria: zero incidence of UADEs.	12 weeks post final treatment
Secondary	Safety: AE's	• Secondary safety endpoint: frequency of device- or procedure-related adverse events, and assessment of side effects.	12 weeks post final treatment
Secondary	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