Nasolabial Folds
Conditions
Keywords
Correction of Nasolabial Folds
Brief summary
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
Detailed description
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
Interventions
DEVICEPerlane and Perlane-L
This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
Sponsors
Q-Med Scandinavia, Inc.
Medicis Global Service Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate \[3\] or both Severe \[4\])
Exclusion criteria
* Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds * Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry * Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry * Permanent implant placed in the Nasolabial Fold area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm | After Injection on Day of Treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Showing Wrinkle Improvement at Day 14 | 14 days after treatment when compared to baseline | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perlane and Perlane-L Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Perlane and Perlane-L |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age Continuous | 53.4 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 60 | 60 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
Time frame: After Injection on Day of Treatment
Population: This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Perlane-L and Perlane | Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm | 95 Participants |
Secondary
Number of Subjects Showing Wrinkle Improvement at Day 14
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Time frame: 14 days after treatment when compared to baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Perlane-L and Perlane | Number of Subjects Showing Wrinkle Improvement at Day 14 | 57 Participants |
| Perlane | Number of Subjects Showing Wrinkle Improvement at Day 14 | 58 Participants |