Trial Outcomes & Findings for Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand (NCT NCT02650921)
NCT ID: NCT02650921
Last Updated: 2022-08-26
Results Overview
A responder is defined as a hand with at least one improvement from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
12 Weeks
Results posted on
2022-08-26
Participant Flow
Unit of analysis: Hands
Participant milestones
| Measure |
All Subjects
Subjects randomized to treatment with Restylane Lyft with Lidocaine in one hand and no treatment in the other
|
|---|---|
|
Overall Study
STARTED
|
92 184
|
|
Overall Study
COMPLETED
|
84 168
|
|
Overall Study
NOT COMPLETED
|
8 16
|
Reasons for withdrawal
| Measure |
All Subjects
Subjects randomized to treatment with Restylane Lyft with Lidocaine in one hand and no treatment in the other
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Due to Medical Condition
|
1
|
Baseline Characteristics
Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
Baseline characteristics by cohort
| Measure |
Restylane Lyft With Lidocaine
n=85 Participants
Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine;
Subjects were randomized to receive Restylane Lyft with Lidocaine in either the right or left hand.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST I (Always burns, never tans)
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST II (Usually burns, tans with difficulty)
|
21 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST III (Sometimes mild burns, gradually tans)
|
39 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST IV (Rarely burns, tans with ease)
|
12 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST V (Very rarely burns, tans with ease)
|
7 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
FST VI (Never burns, tans very easily)
|
2 Participants
n=5 Participants
|
|
Hand Grading Scale - Treated hand
0 (No loss of fatty tissue)
|
0 Participants
n=5 Participants
|
|
Hand Grading Scale - Treated hand
1 (Mild loss of fatty tissue)
|
0 Participants
n=5 Participants
|
|
Hand Grading Scale - Treated hand
2 (Moderate loss of fatty tissue)
|
27 Participants
n=5 Participants
|
|
Hand Grading Scale - Treated hand
3 (Severe loss of fatty tissue)
|
31 Participants
n=5 Participants
|
|
Hand Grading Scale - Treated hand
4 (Very severe loss of fatty tissue)
|
27 Participants
n=5 Participants
|
|
Hand Grading Scale - Fellow Hand
0 (No loss of fatty tissue)
|
0 Participants
n=5 Participants
|
|
Hand Grading Scale - Fellow Hand
1 (Mild loss of fatty tissue)
|
0 Participants
n=5 Participants
|
|
Hand Grading Scale - Fellow Hand
2 (Moderate loss of fatty tissue)
|
18 Participants
n=5 Participants
|
|
Hand Grading Scale - Fellow Hand
3 (Severe loss of fatty tissue)
|
39 Participants
n=5 Participants
|
|
Hand Grading Scale - Fellow Hand
4 (Very severe loss of fatty tissue)
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: ITT population
A responder is defined as a hand with at least one improvement from baseline.
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=85 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=85 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Responder Rate Using Validated Hand Grading Scale
Responder
|
73 Participants
|
18 Participants
|
|
Responder Rate Using Validated Hand Grading Scale
Non-Responder
|
12 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ITT
A responder is defined as a hand with at least one point improvement from baseline
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Responder Rate Using Validated Hand Grading Scale
Responder
|
76 Participants
|
16 Participants
|
|
Responder Rate Using Validated Hand Grading Scale
Non-Responder
|
7 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: ITT
A responder is defined as a hand with at least one point improvement from baseline
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=82 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=82 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Responder Rate Using Validated Hand Grading Scale
Responder
|
68 Participants
|
21 Participants
|
|
Responder Rate Using Validated Hand Grading Scale
Non-Responder
|
14 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT
A responder is defined as a hand with at least one point improvement from baseline.
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Responder Rate Using Validated Hand Grading Scale
Responder
|
63 Participants
|
25 Participants
|
|
Responder Rate Using Validated Hand Grading Scale
Non-Responder
|
20 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=84 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Improvement in Hand as Evaluated by IPR
Yes
|
74 Participants
|
16 Participants
|
|
Improvement in Hand as Evaluated by IPR
No
|
10 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ITT
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Improvement in Hand as Evaluated by IPR
Yes
|
71 Participants
|
17 Participants
|
|
Improvement in Hand as Evaluated by IPR
No
|
12 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: ITT
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=82 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=82 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Improvement in Hand as Evaluated by IPR
Yes
|
57 Participants
|
13 Participants
|
|
Improvement in Hand as Evaluated by IPR
No
|
25 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT
Independent Photographic Reviewer's assessment of improvement (Yes/No)
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Improvement in Hand as Evaluated by IPR
Yes
|
71 Participants
|
18 Participants
|
|
Improvement in Hand as Evaluated by IPR
No
|
12 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=84 Participants
Hands randomized to no treatment
|
|---|---|---|
|
GAIS by Treating Investigator
Very much improved
|
40 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Much improved
|
37 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Improved
|
6 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
No change
|
1 Participants
|
84 Participants
|
|
GAIS by Treating Investigator
Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
GAIS by Treating Investigator
Very much improved
|
40 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Much improved
|
36 Participants
|
1 Participants
|
|
GAIS by Treating Investigator
Improved
|
5 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
No change
|
1 Participants
|
82 Participants
|
|
GAIS by Treating Investigator
Worse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=82 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=82 Participants
Hands randomized to no treatment
|
|---|---|---|
|
GAIS by Treating Investigator
Very much improved
|
33 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Much improved
|
40 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Improved
|
8 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
No change
|
1 Participants
|
82 Participants
|
|
GAIS by Treating Investigator
Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
GAIS by Treating Investigator
Very much improved
|
24 Participants
|
1 Participants
|
|
GAIS by Treating Investigator
Much improved
|
45 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
Improved
|
10 Participants
|
0 Participants
|
|
GAIS by Treating Investigator
No change
|
3 Participants
|
82 Participants
|
|
GAIS by Treating Investigator
Worse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=84 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Evaluate GAIS by Subjects
Very much improved
|
34 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
Much improved
|
30 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
Improved
|
18 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
No change
|
1 Participants
|
84 Participants
|
|
Evaluate GAIS by Subjects
Worse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Evaluate GAIS by Subjects
Very much improved
|
27 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
Much improved
|
31 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
Improved
|
21 Participants
|
2 Participants
|
|
Evaluate GAIS by Subjects
No change
|
4 Participants
|
81 Participants
|
|
Evaluate GAIS by Subjects
Worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=82 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=82 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Evaluate GAIS by Subjects
Very much improved
|
21 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
Much improved
|
34 Participants
|
1 Participants
|
|
Evaluate GAIS by Subjects
Improved
|
22 Participants
|
0 Participants
|
|
Evaluate GAIS by Subjects
No change
|
5 Participants
|
80 Participants
|
|
Evaluate GAIS by Subjects
Worse
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT
Global Aesthetic Improvement Scale
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
n=83 Participants
Hands randomized to no treatment
|
|---|---|---|
|
Evaluate GAIS by Subject
Very much improved
|
21 Participants
|
0 Participants
|
|
Evaluate GAIS by Subject
Much improved
|
26 Participants
|
1 Participants
|
|
Evaluate GAIS by Subject
Improved
|
30 Participants
|
1 Participants
|
|
Evaluate GAIS by Subject
No change
|
5 Participants
|
80 Participants
|
|
Evaluate GAIS by Subject
Worse
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 1 From Subject Satisfaction Questionnaire
Agree
|
77 Participants
|
—
|
|
Question 1 From Subject Satisfaction Questionnaire
Do Not Agree
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 2: My treated hand appears more attractive than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 2 From Subject Satisfaction Questionnaire
Agree
|
74 Participants
|
—
|
|
Question 2 From Subject Satisfaction Questionnaire
Do Not Agree
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 3: My treated hand looks more youthful than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 3 From Subject Satisfaction Questionnaire
Agree
|
75 Participants
|
—
|
|
Question 3 From Subject Satisfaction Questionnaire
Do Not Agree
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 4: My treated hand feels softer than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 4 From Subject Satisfaction Questionnaire
Agree
|
44 Participants
|
—
|
|
Question 4 From Subject Satisfaction Questionnaire
Do Not Agree
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 5: The skin on my treated hand appears tighter than on my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 5 From Subject Satisfaction Questionnaire
Agree
|
64 Participants
|
—
|
|
Question 5 From Subject Satisfaction Questionnaire
Do Not Agree
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 6: My treated hand looks less bony than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 6 From Subject Satisfaction Questionnaire
Agree
|
78 Participants
|
—
|
|
Question 6 From Subject Satisfaction Questionnaire
Do Not Agree
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 7: The veins on my treated hand are less apparent compared to my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 7 From Subject Satisfaction Questionnaire
Agree
|
81 Participants
|
—
|
|
Question 7 From Subject Satisfaction Questionnaire
Do Not Agree
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 8: My treated hand appears at least 5 years younger than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 8 From Subject Satisfaction Questionnaire
Agree
|
59 Participants
|
—
|
|
Question 8 From Subject Satisfaction Questionnaire
Do Not Agree
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 9: My treated hand appears at least 10 years younger than my untreated hand
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 9 From Subject Satisfaction Questionnaire
Agree
|
26 Participants
|
—
|
|
Question 9 From Subject Satisfaction Questionnaire
Do Not Agree
|
58 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 10: The skin on my treated hand appears hydrated
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=83 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 10 From Subject Satisfaction Questionnaire
Agree
|
57 Participants
|
—
|
|
Question 10 From Subject Satisfaction Questionnaire
Do Not Agree
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 11: The treatment result looks natural
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 11 From Subject Satisfaction Questionnaire
Agree
|
80 Participants
|
—
|
|
Question 11 From Subject Satisfaction Questionnaire
Do Not Agree
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 12: I would recommend this treatment to a friend
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 12 From Subject Satisfaction Questionnaire
Agree
|
71 Participants
|
—
|
|
Question 12 From Subject Satisfaction Questionnaire
Do Not Agree
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Question 13: I would have another treatment to maintain these results
Outcome measures
| Measure |
Restylane Lyft With Lidocaine
n=84 Participants
Hands randomized to treatment with Restylane Lyft with Lidocaine
|
No Intervention
Hands randomized to no treatment
|
|---|---|---|
|
Question 13 From Subject Satisfaction Questionnaire
Agree
|
65 Participants
|
—
|
|
Question 13 From Subject Satisfaction Questionnaire
Do Not Agree
|
19 Participants
|
—
|
Adverse Events
Restylane Lyft With Lidocaine
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Lyft With Lidocaine
n=89 participants at risk
Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine
|
|---|---|
|
General disorders
Peripheral Swelling
|
4.5%
4/89 • Number of events 6 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.7%
6/89 • Number of events 6 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Scratch
|
6.7%
6/89 • Number of events 7 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
5/89 • Number of events 7 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Bronchitis
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Sinusitis
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Tooth Infection
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
2/89 • Number of events 3 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
2/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Eye disorders
Vitreous Detachment
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
General disorders
Cyst Rupture
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
General disorders
Device Failure
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
General disorders
Facial Pain
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
General disorders
Influenza like illness
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Chronic Sinusitis
|
1.1%
1/89 • Number of events 2 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Onychomycosis
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Oral Herpes
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Eye Injury
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Injury, poisoning and procedural complications
Nail Injury
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
|
Investigations
Blood Cholesterol Increased
|
1.1%
1/89 • Number of events 1 • 32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
|
Additional Information
Assoc Director of Clinical Operations
Galderma Research & Development, LLC
Phone: 817-961-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place