Trial Outcomes & Findings for A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production (NCT NCT01686841)

Last Updated: 2025-09-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 2 weeks post-treatment

Results posted on

2025-09-18

Participant Flow

A total of 11 participants were enrolled and received treatment with the Zeltiq System using at -10C (Group 1) or -15C (Group 2). Each participant had 3 sites identified on their backs: 1 control site (no treatment) and 2 treatment sites.

Unit of analysis: Treatment Sites

Participant milestones

Participant milestones
Measure	Sebum ReductionTreatment Group 1 (-10C CoolSculpting Treatment) Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C and no treatment was received on 1 control site.	Sebum Reduction Treatment Group 2 (-15C CoolSculpting Treatment) Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C and no treatment was received on 1 control site.
Overall Study STARTED	6 18	5 15
Overall Study Control Site	6 6	5 5
Overall Study Treatment Sites	6 12	5 10
Overall Study COMPLETED	6 18	5 15
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sebum ReductionTreatment Group 1 (-10C CoolSculpting Treatment) n=6 Participants Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C.	Sebum Reduction Treatment Group 2 (-15C CoolSculpting Treatment) n=5 Participants Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants	5 Participants n=5 Participants	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	5 Participants n=5 Participants	11 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	5 participants n=5 Participants	11 participants n=11 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-treatment

Population: All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment). Treatment Sites A and B were averaged.

Outcome measures

Outcome measures
Measure	Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) n=12 treatment sites Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C; Participants were treated on site 1A of the upper back for a single 20 minute treatment with the Zeltiq System using -10C. Participants were treated on site 1B of the upper back for two 10 minute treatments with the Zeltiq System using -10C. Sites A and B were averaged.	Sebum Reduction Treatment Group 1C (Control Site) n=6 treatment sites Participants received no treatment to the control site 1C.	Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) n=10 treatment sites Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C; Participants were treated on site 2A of the upper back for a single 20 minute treatment with the Zeltiq System using -15C. Participants were treated on site 2B of the upper back for two 10 minute treatments with the Zeltiq System using -15C. Sites A and B were averaged.	Sebum Reduction Treatment Group 2C (Control Site) n=5 treatment sites Participants received no treatment to the control site 2C.	Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) Participants were treated on 1 site of the upper back for two 10 minute treatments the Zeltiq System using -15C.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment on the 1 control site.
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.	-10.9 Percent change from baseline Standard Deviation 22.8	6.9 Percent change from baseline Standard Deviation 11.1	7.8 Percent change from baseline Standard Deviation 74.1	45.0 Percent change from baseline Standard Deviation 103.7	—	—

PRIMARY outcome

Timeframe: Time of enrollment through final 4-week follow-up visit

Population: All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment).

The frequency of unanticipated adverse device effects (UADEs) reported throughout the study will be tabulated. Acceptance criteria: zero incidence of UADEs.

Outcome measures

Outcome measures
Measure	Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) n=6 Participants Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C; Participants were treated on site 1A of the upper back for a single 20 minute treatment with the Zeltiq System using -10C. Participants were treated on site 1B of the upper back for two 10 minute treatments with the Zeltiq System using -10C. Sites A and B were averaged.	Sebum Reduction Treatment Group 1C (Control Site) n=5 Participants Participants received no treatment to the control site 1C.	Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C; Participants were treated on site 2A of the upper back for a single 20 minute treatment with the Zeltiq System using -15C. Participants were treated on site 2B of the upper back for two 10 minute treatments with the Zeltiq System using -15C. Sites A and B were averaged.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment to the control site 2C.	Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) Participants were treated on 1 site of the upper back for two 10 minute treatments the Zeltiq System using -15C.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment on the 1 control site.
The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.	0 events	0 events	—	—	—	—

SECONDARY outcome

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

Population: All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or-15C CoolSculpting Treatment).

Device- or procedure related adverse events will be tabulated; side effects of treatment will be assessed.

Outcome measures

Outcome measures
Measure	Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) n=6 Participants Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C; Participants were treated on site 1A of the upper back for a single 20 minute treatment with the Zeltiq System using -10C. Participants were treated on site 1B of the upper back for two 10 minute treatments with the Zeltiq System using -10C. Sites A and B were averaged.	Sebum Reduction Treatment Group 1C (Control Site) n=5 Participants Participants received no treatment to the control site 1C.	Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C; Participants were treated on site 2A of the upper back for a single 20 minute treatment with the Zeltiq System using -15C. Participants were treated on site 2B of the upper back for two 10 minute treatments with the Zeltiq System using -15C. Sites A and B were averaged.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment to the control site 2C.	Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) Participants were treated on 1 site of the upper back for two 10 minute treatments the Zeltiq System using -15C.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment on the 1 control site.
The Number of Device- or Procedure-related Adverse Events Will be Tabulated.	0 events	0 events	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) n=12 treatment sites Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C; Participants were treated on site 1A of the upper back for a single 20 minute treatment with the Zeltiq System using -10C. Participants were treated on site 1B of the upper back for two 10 minute treatments with the Zeltiq System using -10C. Sites A and B were averaged.	Sebum Reduction Treatment Group 1C (Control Site) n=6 treatment sites Participants received no treatment to the control site 1C.	Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) n=10 treatment sites Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C; Participants were treated on site 2A of the upper back for a single 20 minute treatment with the Zeltiq System using -15C. Participants were treated on site 2B of the upper back for two 10 minute treatments with the Zeltiq System using -15C. Sites A and B were averaged.	Sebum Reduction Treatment Group 2C (Control Site) n=5 treatment sites Participants received no treatment to the control site 2C.	Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) Participants were treated on 1 site of the upper back for two 10 minute treatments the Zeltiq System using -15C.	Sebum Reduction Treatment Group 2C (Control Site) Participants received no treatment on the 1 control site.
Percent Change From Baseline of Sebum Production as Measured With Sebutape 72 hours post treatment	10.1 percent change from baseline Standard Deviation 27.3	-9.7 percent change from baseline Standard Deviation 15.3	10.8 percent change from baseline Standard Deviation 26.3	26.7 percent change from baseline Standard Deviation 56.0	—	—
Percent Change From Baseline of Sebum Production as Measured With Sebutape 1 week post treatment	-17.0 percent change from baseline Standard Deviation 13.4	-4.2 percent change from baseline Standard Deviation 10.2	46.0 percent change from baseline Standard Deviation 76.8	86.7 percent change from baseline Standard Deviation 110.2	—	—
Percent Change From Baseline of Sebum Production as Measured With Sebutape 4 weeks post treatment	3.0 percent change from baseline Standard Deviation 26.2	6.9 percent change from baseline Standard Deviation 19.3	41.0 percent change from baseline Standard Deviation 58.9	43.3 percent change from baseline Standard Deviation 77.8	—	—

SECONDARY outcome

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

Population: All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment).

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.