Trial Outcomes & Findings for Study to Evaluate Satisfaction After Treatment With Kysse (NCT NCT03967444)
NCT ID: NCT03967444
Last Updated: 2022-08-26
Results Overview
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
8 weeks after last treatment
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Restylane Kysse
Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation
|
Restylane Kysse With Other HA
Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
40
|
|
Overall Study
COMPLETED
|
18
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Restylane Kysse
Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation
|
Restylane Kysse With Other HA
Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Study to Evaluate Satisfaction After Treatment With Kysse
Baseline characteristics by cohort
| Measure |
Restylane Kysse
n=19 Participants
Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation
|
Restylane Kysse With Other HA
n=40 Participants
Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 10.53 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
40 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after last treatmentThe 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
Outcome measures
| Measure |
Restylane Kysse
n=18 Participants
Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation
|
Restylane Kysse With Other HA
n=38 Participants
Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
|
|---|---|---|
|
Assess Treatment With Restylane Kysse Using GAIS
|
18 Participants
|
38 Participants
|
Adverse Events
Restylane Kysse
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Restylane Kysse With Other HA
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Kysse
n=19 participants at risk
Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation
|
Restylane Kysse With Other HA
n=40 participants at risk
Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
|
|---|---|---|
|
General disorders
Implant Site Bruising
|
31.6%
6/19 • Number of events 8 • 8 weeks
|
42.5%
17/40 • Number of events 31 • 8 weeks
|
|
General disorders
Implant Site Pain
|
31.6%
6/19 • Number of events 12 • 8 weeks
|
35.0%
14/40 • Number of events 41 • 8 weeks
|
|
General disorders
Implant Site Oedema
|
36.8%
7/19 • Number of events 15 • 8 weeks
|
22.5%
9/40 • Number of events 23 • 8 weeks
|
|
General disorders
Impalnt site erythema
|
15.8%
3/19 • Number of events 5 • 8 weeks
|
25.0%
10/40 • Number of events 21 • 8 weeks
|
|
General disorders
Implant Site Swelling
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
7.5%
3/40 • Number of events 3 • 8 weeks
|
|
General disorders
Implant Site Reaction
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
General disorders
Implant Site Dysaesthesia
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
0.00%
0/19 • 8 weeks
|
2.5%
1/40 • Number of events 1 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 1 • 8 weeks
|
0.00%
0/40 • 8 weeks
|
Additional Information
Director of Clinical Operations
Galderma Research & Development, Aesthetics
Phone: 817-961-5655
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place