Peri-oral Wrinkles
Conditions
Keywords
Correction of peri-oral wrinkles
Brief summary
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
Interventions
DEVICERestylane and Perlane
Sponsors
Medicis Global Service Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Same Wrinkle Severity (either both Moderate \[3\] or both Severe \[4\]) of marionette lines and upper peri-oral rhytids
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 | Description |
|---|---|---|
| Local and Systemic Adverse Events | 2-weeks | To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perlane and Restylane Perlane and Restylane used open label to correct peri-oral wrinkles | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Perlane and Restylane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 59.6 years STANDARD_DEVIATION 4.04 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Local and Systemic Adverse Events
To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)
Time frame: 2-weeks
Population: Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane and Perlane | Local and Systemic Adverse Events | 100 percentage of participants |