Wrinkles
Conditions
Keywords
Nasolabial Folds, Cosmetic, Injectable Dermal Filler, Hyaluronic Acid with Lidocaine
Brief summary
Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products. This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess. 1\. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)
Detailed description
This study is designed to be an open-label, longitudinal, uncontrolled study in a minimum of 100 subjects with Fitzpatrick scale skin type of IV, V or VI at 10 or more U.S. centers who have elected to undergo NLF treatment with intradermal (deep dermal) injection of Elevess. Subjects will be followed for a minimum of 24 weeks with visit assessments at 2, 6, 12 and 24 weeks after the last injection. Safety: Primary Safety Endpoint assessments will be: 1) keloid formation at the site of injection at 2, 6, 12 and 24 weeks, 2) pigmentation changes at the site of injection compared to adjacent skin at 2, 6, 12 and 24 weeks, and 3) overall adverse events. A subject diary will also be collected. Effectiveness: No formal effectiveness evaluation will be performed.
Interventions
DEVICEElevess
Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fitzpatrick skin type of IV, V or VI. * Bilateral nasolabial folds which, in the investigator's judgment, can be corrected with Elevess. * Age greater or equal to 18 years.
Exclusion criteria
* Fitzpatrick skin type of I, II or III. * Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies. * Subject has allergies to the components of Elevess: hyaluronic acid, lidocaine, sodium metabisulfite or gram positive bacterial proteins. * Subject has a history of severe keloids and/or hypertrophic scars. * Subject has ever received any soft tissue augmentation in any area of the face and subject is unwilling to forgo all other soft tissue augmentation for the duration of the study. * Subject has received any aesthetic or dermatologic treatments or procedures in any area of the face in the previous 6 months and subject is unwilling to forgo such treatments or procedures for the duration of the study. * Subject has active facial acne lesions, severe acne scarring or pigmentation disorders at the injection site that might affect clinical assessment of the nasolabial folds. * Subject has ever received an injection or implant of silicone in any area of the face. * Subject has received immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months. * Subject has a history of a connective tissue disease. * Subject is positive for HIV/AIDS or hepatitis C. * Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keloid Formation at Site of Injection | 2 Weeks | Percentage of Subjects with keloid formation at the site of injection |
| Pigmentation Changes at Site of Injection | 2 Weeks | Percentage of Subjects with pigmentation changes at site of injection |
Countries
United States
Participant flow
Recruitment details
A total of 122 subjects were screened for the study at 9 centers. Twenty-two screen failed and 100 were were enrolled in this study. No subject who failed screening was treated during the CTA-0701 study. Of the treated subjects 96% completed the follow-up visit 24 weeks after Treatment.
Pre-assignment details
Elevess was injected into the mid to deep dermis of each nasolabial fold. Subjects were telephoned at 72 (±24) hours to assess the subjects for possible AEs and injection site reactions. All subjects returned 14 ± 3 days after initial treatment for evaluation of AEs and to assess whether a Touch-up was needed.
Participants by arm
| Arm | Count |
|---|---|
| Elevess Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Elevess |
|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 53 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Time frame: 6 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Keloid Formation at Site of Injection | 0.0 Percentage (%) of subjects |
Primary
Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Time frame: 12 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Keloid Formation at Site of Injection | 0.0 Percentage (%) of subjects |
Primary
Keloid Formation at Site of Injection
Percentage of subjects with keloid formation at the site of injection at End of Study
Time frame: 24 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Keloid Formation at Site of Injection | 0.0 Percentage (%) of subjects |
Primary
Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Time frame: 2 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Keloid Formation at Site of Injection | 0.0 percentage of participants |
Primary
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Time frame: 2 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Pigmentation Changes at Site of Injection | 8.0 Percentage (%) of subjects |
Primary
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Time frame: 12 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Pigmentation Changes at Site of Injection | 2.0 Percentage (%) of subjects |
Primary
Pigmentation Changes at Site of Injection
Percentage of subjects with pigmentation changes at site of injection at End of Study
Time frame: 24 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Pigmentation Changes at Site of Injection | 1.0 Percentage (%) of subjects |
Primary
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Time frame: 6 Weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevess | Pigmentation Changes at Site of Injection | 3.0 Percentage (%) of subjects |