Trial Outcomes & Findings for Effects on Cellulite Appearance (NCT NCT04876118)
NCT ID: NCT04876118
Last Updated: 2025-03-10
Results Overview
Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.
COMPLETED
NA
97 participants
Week 12 post final treatment (up to 24 weeks after first treatment)
2025-03-10
Participant Flow
Participant milestones
| Measure |
CoolSculpting of the Thigh
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
Received at Least 1 Study Treatment
|
97
|
|
Overall Study
Per Protocol Population
|
74
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
CoolSculpting of the Thigh
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
Baseline Characteristics
Effects on Cellulite Appearance
Baseline characteristics by cohort
| Measure |
CoolSculpting of the Thigh
n=97 Participants
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 post final treatment (up to 24 weeks after first treatment)Population: Per Protocol population consisted of all treated participants who 2 treatments, and weight change of no more than 5% of total body weight at the time the assessments were performed compared to the weight obtained at the first treatment visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.
Outcome measures
| Measure |
CoolSculpting of the Thigh
n=73 Participants
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
|
55.7 % of images identified correctly
|
SECONDARY outcome
Timeframe: Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)Population: The Safety Population consisted of all enrolled participants who received at least 1 treatment.
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious AE was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An adverse devise effect (ADE) was any sign, symptom, or disease determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of a serious AE.
Outcome measures
| Measure |
CoolSculpting of the Thigh
n=97 Participants
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
SADEs
|
0 Participants
|
|
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
Device and/or Procedure Related AEs
|
3 Participants
|
Adverse Events
CoolSculpting of the Thigh
Serious adverse events
| Measure |
CoolSculpting of the Thigh
n=97 participants at risk
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Gastrointestinal disorders
Food Poisoning
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Reproductive system and breast disorders
Atypical lump of cells in left breast
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
General disorders
Fever
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
Other adverse events
| Measure |
CoolSculpting of the Thigh
n=97 participants at risk
Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.
|
|---|---|
|
General disorders
Reaction post COVID-19 booster
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Musculoskeletal and connective tissue disorders
Broken foot
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Musculoskeletal and connective tissue disorders
Right arm fracture
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Infections and infestations
COVID-19
|
3.1%
3/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster (Shingles)
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.1%
3/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
|
Skin and subcutaneous tissue disorders
Contour irregularity
|
1.0%
1/97 • Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
The Safety Population consisted of all enrolled participants who received at least 1 treatment.
|
Additional Information
Sally Hallas, RN, Director Clinical Development - Body Contouring
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER