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

NCT01686841 | Completed Results FDA Device

• 1 other identifier: ZA12-003
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne

Keywords

Cryolipolysis; Sebum

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The Number of Device- or Procedure-related Adverse Events Will be Tabulated.

  Time of enrollment through the final 4-week follow-up visit

• Percent Change From Baseline of Sebum Production as Measured With Sebutape

  72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment

• Number of Side Effect Events Post-treatment by Severity.

  Post-treatment to 4-week final follow-up visit

Study Arms (1)

Sebum Reduction

EXPERIMENTAL

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

Interventions

The Zeltiq System DEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis

Sebum Reduction

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Lori Brandt, Director Clinical Trial Management
• Organization: Zeltiq Aesthetics

lori.brandt@abbvie.com

(925) 621-7460

Study Officials

• Rox Anderson, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 18, 2012
• Study Start: August 16, 2012
• Primary Completion: April 29, 2013
• Study Completion: December 31, 2013
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)