Acne
Conditions
Keywords
Cryolipolysis, Sebum
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.
Interventions
DEVICEThe Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects \>18 years of age and \<25 years of age. 2. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter 3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A) 4. Willingness to participate in the study 5. Willingness to receive EXPERIMENTAL treatment 6. Informed consent agreement signed by the subject 7. Willingness to follow the treatment schedule and post treatment care requirements 8. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment
Exclusion criteria
1. Subject has a history of isotretinoin use 2. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated 3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria 4. Presence of suntan in the area to be treated 5. Subject is immunosuppressed 6. Subject is unable to comply with treatment, home care or follow-up visits 7. Subject has a history of vitiligo 8. Subject has a history of keloid formation 9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sebum ReductionTreatment Group 1 (-10C CoolSculpting Treatment) Participants were treated on 2 treatment sites on the upper back with the Zeltiq System using -10C. | 6 |
| 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. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Sebum Reduction Treatment Group 2 (-15C CoolSculpting Treatment) | Total | Sebum ReductionTreatment Group 1 (-10C CoolSculpting Treatment) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 5 participants | 11 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | 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 |
| Sebum Reduction Treatment Group 1C (Control Site) | Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. | 6.9 Percent change from baseline | Standard Deviation 11.1 |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. | 7.8 Percent change from baseline | Standard Deviation 74.1 |
| Sebum Reduction Treatment Group 2C (Control Site) | Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. | 45.0 Percent change from baseline | Standard Deviation 103.7 |
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated. | 0 events |
| Sebum Reduction Treatment Group 1C (Control Site) | The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated. | 0 events |
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 2 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 1 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 5 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 4 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 4 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 2 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 6 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 6 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 5 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 2 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 1 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 4 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 4 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 2 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 1C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 6 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 2 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 3 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 3 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 5 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 2 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 5 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2B (-15C CoolSculpting Treatment) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura -severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura - severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia-severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema-moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia -minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment dysesthesia =absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post-treatment edema- severe | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema/swelling-absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment erythema/purpura-absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment treatment edema -moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | immediate post treatment erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura-absent | 5 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | Immediate post treatment edema-minor | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U erythema/purpura- moderate | 0 treatment sites |
| Sebum Reduction Treatment Group 2C (Control Site) | Number of Side Effect Events Post-treatment by Severity. | 4 week F/U dysesthesia- absent | 5 treatment sites |
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.
Time frame: 72 hours post-treatment, 1 week post-treatment and 4 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | 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 |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | 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 |
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | 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 |
| Sebum Reduction Treatment Group 1C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 72 hours post treatment | -9.7 percent change from baseline | Standard Deviation 15.3 |
| Sebum Reduction Treatment Group 1C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 4 weeks post treatment | 6.9 percent change from baseline | Standard Deviation 19.3 |
| Sebum Reduction Treatment Group 1C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 1 week post treatment | -4.2 percent change from baseline | Standard Deviation 10.2 |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 1 week post treatment | 46.0 percent change from baseline | Standard Deviation 76.8 |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 72 hours post treatment | 10.8 percent change from baseline | Standard Deviation 26.3 |
| Sebum Reduction Treatment Group 2A and 2B (-15C CoolSculpting Treatment) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 4 weeks post treatment | 41.0 percent change from baseline | Standard Deviation 58.9 |
| Sebum Reduction Treatment Group 2C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 72 hours post treatment | 26.7 percent change from baseline | Standard Deviation 56 |
| Sebum Reduction Treatment Group 2C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 4 weeks post treatment | 43.3 percent change from baseline | Standard Deviation 77.8 |
| Sebum Reduction Treatment Group 2C (Control Site) | Percent Change From Baseline of Sebum Production as Measured With Sebutape | 1 week post treatment | 86.7 percent change from baseline | Standard Deviation 110.2 |
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sebum Reduction Treatment Group 1A and 1B (-10C CoolSculpting Treatment) | The Number of Device- or Procedure-related Adverse Events Will be Tabulated. | 0 events |
| Sebum Reduction Treatment Group 1C (Control Site) | The Number of Device- or Procedure-related Adverse Events Will be Tabulated. | 0 events |