Trial Outcomes & Findings for Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency (NCT NCT03289052)
NCT ID: NCT03289052
Last Updated: 2023-05-12
Results Overview
Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
6 month
Results posted on
2023-05-12
Participant Flow
Participant milestones
| Measure |
Group A
The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
|
Group B-Restylane Volyme Treatment Arm
Including treatment arm. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
|
Group B- Control Arm
Including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment. A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
111
|
37
|
|
Overall Study
COMPLETED
|
20
|
108
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Baseline characteristics by cohort
| Measure |
Group A
n=20 Participants
The first 2 eligible subjects for each Treating Investigator will receive treatment as Group A.
|
Restylane Volyme Treatment Group of Group B
n=111 Participants
Subjects assigned in this group will receive Restylane Volyme treatment at day 1.
|
Control Group of Group B
n=37 Participants
Subjects assigned in this group will receive no treatment at day 1, but at 6m visit.
|
Total
n=168 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese Han
|
20 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
20 participants
n=5 Participants
|
111 participants
n=7 Participants
|
37 participants
n=5 Participants
|
168 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthPercentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.
Outcome measures
| Measure |
Group A
n=20 Participants
The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site.
|
Group B-treatment Arm
n=111 Participants
Subject assigned in this group will receive Restylane Volyme treatment at D1.
|
Group B-control Arm
n=37 Participants
Subject assigned in this group will not receive Restylane Volyme treatment at D1 but on 6M visit.
|
|---|---|---|---|
|
Percentage of Responders
|
80 percentage of subjects
Interval 56.3 to 94.3
|
87.2 percentage of subjects
Interval 79.4 to 92.8
|
76.7 percentage of subjects
Interval 57.7 to 90.1
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B-treatment Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B-control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=20 participants at risk
The first 2 eligible subjects for each Treating Investigator will receive Restylane Volyme treatment as Group A. The injection technique will be evaluated by the Sponsor and performed after the subjects in Group A for each site have received their first treatment. If treatments are found to be correctly performed, no further training is needed, there are no outstanding questions regarding the injection technique and no other corrective actions are identified, the enrolment in Group B can start for that site.
A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
|
Group B-treatment Arm
n=111 participants at risk
including treatment arm A maximum dosage of 2 mL per treatment site (i.e., right and left midface respectively) is recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively.
|
Group B-control Arm
n=37 participants at risk
including control arm Subjects assigned to the Control Group in Group B will not receive treatment at baseline but will return for routine follow-up for 12 months. At month 6 visit, subjects in Control Group will be offered a treatment and an optional touch-up treatment.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage 0
|
5.0%
1/20 • Number of events 1 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
0.00%
0/111 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
0.00%
0/37 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/20 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
0.90%
1/111 • Number of events 1 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
0.00%
0/37 • 1 year.
Each subject will be questioned about AEs at each clinical visit following the screening visit. The question asked will be "Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place