Trial Outcomes & Findings for Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root (NCT NCT02216851)
NCT ID: NCT02216851
Last Updated: 2022-08-26
Results Overview
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
6 months
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Restylane Perlane
Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Restylane Perlane: Intradermal injection
|
No-treatment Control
No-treatment control group do not receive any treatment during the main study period
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
33
|
|
Overall Study
COMPLETED
|
96
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
Baseline characteristics by cohort
| Measure |
Restylane Perlane
n=98 Participants
Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Restylane Perlane: Intradermal injection
|
No-treatment Control
n=33 Participants
No-treatment control group do not receive any treatment during the main study period
|
Total
n=131 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
|
98 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
Outcome measures
| Measure |
Restylane Perlane
n=98 Participants
Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Restylane Perlane: Intradermal injection
|
No-treatment Control
n=33 Participants
No-treatment control group do not receive any treatment during the main study period
|
|---|---|---|
|
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
|
0.82 mL
Standard Error 0.03
|
0.11 mL
Standard Error 0.03
|
Adverse Events
Restylane Perlane
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
No-treatment Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane Perlane
n=98 participants at risk
Single injection of Restylane Perlane in nasal dorsum and/or nasal root
Restylane Perlane: Intradermal injection
|
No-treatment Control
n=33 participants at risk
No-treatment control group do not receive any treatment during the main study period
|
|---|---|---|
|
Metabolism and nutrition disorders
mixed hemorrhoids
|
0.00%
0/98 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
3.0%
1/33 • Number of events 1 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
|
Hepatobiliary disorders
Solid pseudopapillary tumor of the pancreas
|
1.0%
1/98 • Number of events 1 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
0.00%
0/33 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
|
Reproductive system and breast disorders
Fallopian tube obstruction
|
1.0%
1/98 • Number of events 1 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
0.00%
0/33 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
|
Respiratory, thoracic and mediastinal disorders
peritoneal adhesions
|
1.0%
1/98 • Number of events 1 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
0.00%
0/33 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/98 • Number of events 1 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
0.00%
0/33 • During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was "Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place