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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq System | Device | Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| 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 |
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rox Anderson, MD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants treated with the Zeltiq System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sebum ReductionTreatment Group 1 (-10C CoolSculpting Treatment) | Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C. |
| BG001 | Sebum Reduction Treatment Group 2 (-15C CoolSculpting Treatment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Percent change from baseline | Baseline and 2 weeks post-treatment | treatment sites | treatment sites |
|
Any adverse event information was collected from the time of study enrollment through the 4-week post-treatment follow-up visit.
The Safety Population consisted of all enrolled participants who received at least one study treatment. Data presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sebum Reduction Treatment Group 1A (-10C CoolSculpting Treatment) | Participants were treated on 1 site of the upper back for a single 20 minute treatment with the Zeltiq System using -10C. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Brandt, Director Clinical Trial Management | Zeltiq Aesthetics | (925) 621-7460 | lori.brandt@abbvie.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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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 |
Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -15C. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | 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. |
| OG001 | Sebum Reduction Treatment Group 1C (Control Site) | Participants received no treatment to the control site 1C. |
| OG002 | 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. |
| OG003 | Sebum Reduction Treatment Group 2C (Control Site) | Participants received no treatment to the control site 2C. |
|
|
| Primary | 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. | All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment). | Posted | Number | events | Time of enrollment through final 4-week follow-up visit |
|
|
|
| Secondary | 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. | All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or-15C CoolSculpting Treatment). | Posted | Number | events | Time of enrollment through the final 4-week follow-up visit |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percent change from baseline | 72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment | treatment sites | treatment sites |
|
|
|
| Secondary | 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. | All enrolled participants presented here, as planned per protocol, by treatment received (-10C CoolSculpting Treatment or -15C CoolSculpting Treatment). | Posted | Number | treatment sites | Post-treatment to 4-week final follow-up visit | Treatment sites | Treatment sites |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Sebum Reduction Treatment Group 1B (-10C CoolSculpting Treatment) | Participants were treated on 1 site of the upper back for two 10 minute treatments with the Zeltiq System using -10C. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Sebum Reduction Treatment Group 1C (Control Site) | Participants received no treatment on the 1 control site. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Sebum Reduction Treatment Group 2A (-15C CoolSculpting Treatment) | Participants were treated on 1 site of the the upper back for a single 20 minute treatment with the Zeltiq System using -15C. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | Sebum Reduction Treatment Group 2C (Control Site) | Participants received no treatment on the 1 control site | 0 | 5 | 0 | 5 | 0 | 5 |
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| treatment sites |
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| 1 week post treatment |
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| 4 weeks post treatment |
|
| Treatment sites |
|
| immediate post treatment erythema/purpura-minor |
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| Immediate post treatment erythema/purpura -moderate |
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| Immediate post treatment erythema/purpura - severe |
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| Immediate post treatment edema/swelling-absent |
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| Immediate post treatment edema-minor |
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| Immediate post treatment treatment edema -moderate |
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| immediate post-treatment edema- severe |
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| Immediate post treatment dysesthesia =absent |
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| Immediate post treatment dysesthesia -minor |
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| Immediate post treatment dysesthesia -moderate |
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| Immediate post treatment dysesthesia-severe |
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| 4 week F/U erythema/purpura-absent |
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| 4 week F/U erythema/purpura-minor |
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| 4 week F/U erythema/purpura- moderate |
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| 4 week F/U erythema/purpura -severe |
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| 4 week F/U edema- absent |
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| 4 week F/U edema -minor |
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| 4 week F/U edema-moderate |
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| 4 week F/U edema- severe |
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| 4 week F/U dysesthesia- absent |
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| 4 week F/U dysesthesia-minor |
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| 4 week F/U dysesthesia-moderate |
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| 4 week F/U dysesthesia-severe |
|