To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
11
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 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 frame: Time of enrollment through final 4-week follow-up visit
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 frame: 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.
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Time frame: 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.
Time frame: Post-treatment to 4-week final follow-up visit