N/A
N=100
Safety Study of Cosmetic Tissue Augmentation in People of Color
Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01147172 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Keloid Formation at Site of Injection — 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Elevess (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anika Therapeutics, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Keloid Formation at Site of Injection |
0.0 | — |
| PRIMARY Keloid Formation at Site of Injection |
0.0 | — |
| PRIMARY Keloid Formation at Site of Injection |
0.0 | — |
| PRIMARY Keloid Formation at Site of Injection |
0.0 | — |
| PRIMARY Pigmentation Changes at Site of Injection |
1.0 | — |
| PRIMARY Pigmentation Changes at Site of Injection |
1.0 | — |
| PRIMARY Pigmentation Changes at Site of Injection |
1.0 | — |
| PRIMARY Pigmentation Changes at Site of Injection |
1.0 | — |
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01147172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.