Trial Outcomes & Findings for Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients (NCT NCT03351335)
NCT ID: NCT03351335
Last Updated: 2019-08-28
Results Overview
Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and Day 90
Results posted on
2019-08-28
Participant Flow
The study was conducted at 7 investigational sites in the United States.
A total of 180 participants were screened, out of which 60 were enrolled and treated. Of these, 56 participants completed the study.
Participant milestones
| Measure |
Group EL 2: Ultherapy
Participants received a single Ultherapy treatment at energy level 2 (EL2) on the lower face, submental (under the chin) and neck area at dual depth using transducer DeepSEE (DS) 4 to 4.5 with treatment frequency 4 megahertz (MHz) and depth 4.5 millimeter (mm) at energy level 0.90 Joule (J), and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
Participants received a single Ultherapy treatment at energy level 3 (EL3) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
Group EL 4: Ultherapy
Participants received a single Ultherapy treatment at energy level 4 (EL4) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Group EL 2: Ultherapy
Participants received a single Ultherapy treatment at energy level 2 (EL2) on the lower face, submental (under the chin) and neck area at dual depth using transducer DeepSEE (DS) 4 to 4.5 with treatment frequency 4 megahertz (MHz) and depth 4.5 millimeter (mm) at energy level 0.90 Joule (J), and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
Participants received a single Ultherapy treatment at energy level 3 (EL3) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
Group EL 4: Ultherapy
Participants received a single Ultherapy treatment at energy level 4 (EL4) on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
|---|---|---|---|
|
Overall Study
Failure to maintain inclusion/exclusion
|
0
|
0
|
4
|
Baseline Characteristics
Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Baseline characteristics by cohort
| Measure |
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
Group EL 4: Ultherapy
n=20 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
51.4 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
52.3 years
STANDARD_DEVIATION 7.5 • n=157 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
56 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
60 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type I
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type II
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type III
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type IV
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
32 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type V
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Type VI
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Fitzpatrick skin type
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 90Population: The full analysis set (FAS) population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).
Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.
Outcome measures
| Measure |
Group EL 4: Ultherapy
n=16 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
|---|---|---|---|
|
Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
|
-22.3 square millimeter (mm^2)
Standard Deviation 38.2
|
-14.4 square millimeter (mm^2)
Standard Deviation 28.0
|
-7.9 square millimeter (mm^2)
Standard Deviation 40.8
|
SECONDARY outcome
Timeframe: Day 90Population: The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).
Overall aesthetic improvement was assessed by a principal investigator using global aesthetic improvement scale (GAIS).The PGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the physician. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement was determined by participant response rate (improved or much improved) on PGAIS.
Outcome measures
| Measure |
Group EL 4: Ultherapy
n=16 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
|---|---|---|---|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment
|
16 Participants
|
18 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 90Population: The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).
Overall aesthetic improvement was assessed by a principal investigator using GAIS. The SGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the participant. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement is determined by participant response rate (improved or much improved) on SGAIS.
Outcome measures
| Measure |
Group EL 4: Ultherapy
n=16 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
|---|---|---|---|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment
|
16 Participants
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 90Population: The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).
Masked, qualitative photographic assessment of photographs were obtained using Mirror Photofile software and a Vectra 3D digital imaging system. Experienced physicians evaluated paired pre- and 90-days post-treatment photographs of evaluable participants in a blinded fashion. Each blinded assessor reviewed the image sets and identified the post-treatment photographs according to the following definitions: Change (A change that is noticeable) and No Change (No change is apparent). Blinded assessors were asked to compare pre- and post-treatment photos for noticeable change. When change was noted the assessors were asked to determine which image demonstrated improvement. Assessor data were compiled and analyzed using majority rule for each participant assessed.
Outcome measures
| Measure |
Group EL 4: Ultherapy
n=16 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
|---|---|---|---|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Improved: Left Side
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Improved: Right Side
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Improved: Both Sides
|
6 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Improved: Either Side
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 90Population: The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).
Participant satisfaction was determined by scores on PSQ completed at 90 days post-treatment. The participant completed this assessment while referring to baseline photos on a sponsor-supplied electronic tablet and a hand mirror. Participants were requested to provide information on "Please indicate what you think about how the treated areas of your lower face and neck look today. With your face relaxed (do not smile), look in the mirror at the treated area on both sides of your face and compare to the photos taken of both sides of your face prior to your study treatment." First questionnaire was as "Compared to when you started the study, how do your lower face, under your chin, and your upper neck look today?" Improved (much improved, improved, little improved), no change, worse. Second questionnaire was "How would you characterize your satisfaction with the treatment?" Satisfied (extremely satisfied, satisfied, slightly satisfied), neither satisfied or dissatisfied, dissatisfied.
Outcome measures
| Measure |
Group EL 4: Ultherapy
n=16 Participants
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
Group EL 2: Ultherapy
n=21 Participants
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 Participants
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
|---|---|---|---|
|
Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
Improved
|
16 Participants
|
18 Participants
|
15 Participants
|
|
Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
Satisfied
|
14 Participants
|
17 Participants
|
13 Participants
|
Adverse Events
Group EL 2: Ultherapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group EL 3: Ultherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group EL 4: Ultherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group EL 2: Ultherapy
n=21 participants at risk
Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline.
|
Group EL 3: Ultherapy
n=19 participants at risk
Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline.
|
Group EL 4: Ultherapy
n=20 participants at risk
Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Bruising/Ecchymosis
|
14.3%
3/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
5.0%
1/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
Skin and subcutaneous tissue disorders
Erythema/Redness
|
14.3%
3/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
Metabolism and nutrition disorders
Edema
|
9.5%
2/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
Skin and subcutaneous tissue disorders
Itching/Pruritus
|
9.5%
2/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
Nervous system disorders
Tingling/Paresthesia/Numbness/ Nerve-related transient pain
|
0.00%
0/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
10.0%
2/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
General disorders
Nausea, Weakness
|
0.00%
0/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
5.0%
1/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
General disorders
Skin Pigmentation Change (Hypo-, Hyperpigmentation)
|
0.00%
0/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
5.3%
1/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
General disorders
Tenderness/Soreness/Pain/ Sensitivity to Touch
|
4.8%
1/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
|
General disorders
Welting/Raised Areas of Edema
|
0.00%
0/21 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
0.00%
0/19 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
5.0%
1/20 • Baseline up to Day 90
The investigator asked the participants for adverse events (AEs) systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER