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

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

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

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Device: The Zeltiq System

Detailed Description

The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sebum Reduction; Subjects enrolled in the study were treated on the back with the Zeltiq System. Two sites on the upper back were selected as test sites and 1 site was used as a control.	Device: The Zeltiq System; Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.; Other Names: Cryolipolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.	Reduction of sebum production as measured by Sebutape at 2 weeks post-treatment. A 30% reduction of sebum production in a treated site compared to baseline Sebutape measurements will be considered clinically meaningful. Sebutape is an adhesive patch that acts as a passive collector of sebum. The gradual displacement of air in the pores of the microporous film changes its appearance. The size of the transparent area is a measure of the amount of sebum collected. All Sebutape measurements were performed in duplicate and the average of the two measurements was used for analysis. Results indicate the mean difference in Sebutape scores from baseline to 2 weeks post-treatment.	Baseline and 2 weeks post-treatment
The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.	The frequency of unanticipated adverse device effects (UADEs) reported throughout the study will be tabulated. Acceptance criteria: zero incidence of UADEs.	Time of enrollment through final 4-week follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Device- or Procedure-related Adverse Events Will be Tabulated.	Device- or procedure related adverse events will be tabulated; side effects of treatment will be assessed.	Time of enrollment through the final 4-week follow-up visit
Percent Change From Baseline of Sebum Production as Measured With Sebutape	Sebum production will be measured using Sebutape at 72 hours, 1 week, and 4 weeks post-treatment. Sebutape is an adhesive patch that acts as a passive collector of sebum. The gradual displacement of air in the pores of the microporous film changes its appearance. The size of the transparent area is a measure of the amount of sebum collected. Sebutape measurements were performed in duplicate. The average of the two readings was used for analysis. Results are expressed in µg/cm² and correspond to the total amount of sebum collected on the film.	72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment
Number of Side Effect Events Post-treatment by Severity.	All treatment sites (-10C vs -15C) were assessed for expected side effects of erythema, edema/swelling and dysesthesia at specific time points of the study. Treatment sites were scored on a 0 to 3 scale, with 0 = absent, 1 =minor, 2 = moderate and 3 = severe.	Post-treatment to 4-week final follow-up visit

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Principal Investigator: Rox Anderson, MD, MGH

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2012
• Primary Completion (Actual): April 29, 2013
• Study Completion (Actual): December 31, 2013

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimated): September 18, 2012

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cryolipolysis; Sebum
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: ZA12-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes