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

Not Applicable

Completed

• Conditions: Acne

• Registration Number: NCT01686841
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2012-08-16
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Primary Completion: 2013-04-29
• Study Completion: 2013-12-31
• Results First Submitted: 2021-11-04
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Results First Posted: 2025-09-18
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.	Baseline and 2 weeks post-treatment	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.
The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.	Time of enrollment through final 4-week follow-up visit	The frequency of unanticipated adverse device effects (UADEs) reported throughout the study will be tabulated. Acceptance criteria: zero incidence of UADEs.

Secondary Outcome Measures

Name	Time	Method
The Number of Device- or Procedure-related Adverse Events Will be Tabulated.	Time of enrollment through the final 4-week follow-up visit	Device- or procedure related adverse events will be tabulated; side effects of treatment will be assessed.
Percent Change From Baseline of Sebum Production as Measured With Sebutape	72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment	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.
Number of Side Effect Events Post-treatment by Severity.	Post-treatment to 4-week final follow-up visit	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States