Infraorbital Hollows
Conditions
Brief summary
The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment
Detailed description
This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.
Interventions
DRUGRestalyne
one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
DRUGPerlane
One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years and older * No significant medical illness * Subjects with the willingness and ability to understand and provide informed consent
Exclusion criteria
* Under 18 years of age * Pregnancy or Lactation * Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area * Subjects with a known allergy to the components in Restylane® or Perlane® * Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months * Subjects with liver/kidney disease or compromise or who are immunocompromised * Subjects with a known susceptibility to keloid formation or hypertrophic scarring * Subjects with an open, non-healing sore or infection near the site of injections * Subjects who are unable to understand the protocol or to give informed consent * Subjects with mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restalyne and Perlane One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
Restalyne: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
Perlane: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 18 |
Baseline characteristics
| Characteristic | Restalyne and Perlane |
|---|---|
| Age, Customized 18-70 years | 0 Participants |
| Sex/Gender, Customized female | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment
Time frame: 1 year
Population: The Principle Investigator left the institution and no data is available.