Status:
COMPLETED
DA-13-007 Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles
Lead Sponsor:
DermAvance
Conditions:
Face; Atrophy
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasola...
Detailed Description
A randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007 (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. ...
Eligibility Criteria
Inclusion
- 1\. Outpatient, male or female subjects of any race 21 years or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline Visit (test must have a sensitivity of at least 50U/mL for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study.
- A female is considered of childbearing potential unless she is
- postmenopausal for at least 12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration.
- Reliable methods of contraception are:
- hormonal methods or intrauterine device in use \>30 days prior to study drug administration; or
- barrier methods plus spermicide in use at least 14 days prior to study drug administration
- vasectomized partner at least 3 months post operative or a zero sperm count post operatively 2. Demonstrate clinical evidence of moderate to severe bilateral aging in the nasolabial area, with wrinkles classified as a grade 3 or grade 4 on a 5-grade WSRS.
- 3\. Committed to abstain from procedures interfering with the treatment outcome (exclusion criteria) throughout the study.
- 4\. Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
Exclusion
- Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response and/or quality of photography.
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart.
- Active skin disease within the treatment area within 6 months prior to study entry.
- History of malignancy, excluding non-melanoma skin cancer within the past 5 years.
- Profound atrophy/excessive weakness of muscles in target areas of injection.
- History of facial nerve palsy.
- Facial wrinkles therapy, such a permanent or enduring dermal fillers in the previous 2 years or bioresorbable during the previous 12 months.
- Allergy or sensitivity to any component of the study medication (Section 8.1), or a known sensitivity to local anesthetics.
- Previous botulinum toxin therapy within six (6) months of the Baseline Visit.
- Use of systemic prednisone, penicillamine, anti metabolites or other bioequivalent collagen production inhibitors within 3 months of the Baseline Visit.
- Has received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or non-steroidal anti inflammatory, eg.,aspirin, ibuprofen), or other substances known to increase coagulation time (e.g., Vitamin E, garlic, gingko). To clarify, no non-steroidal anti inflammatory e.g. asprin or ibuprofen within 10 days prior to injections or 3 days post injection.
- Evidence of recent alcohol or drug abuse.
- Medical and/or psychiatric problems that, in the Investigator's opinion, is severe enough to interfere with the study results.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Participation in an investigational drug or investigational device study within 3 months of the Baseline Visit.
- A history of connective tissue disease (rheumatoid Arthritis, arthritis, lupus).
- A history of multiple severe allergies or a history of anaphylactic shock.
- Patients with a known history of or susceptibility to keloid formation or hypertrophic scarring.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT02310490
Start Date
January 1 2015
End Date
December 1 2018
Last Update
August 1 2024
Active Locations (4)
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1
Bay Area Dermatology
Bradenton, Florida, United States, 34209
2
Miami Skin Institute
Coral Gables, Florida, United States, 33146
3
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States, 46032
4
PCR
Spokane, Washington, United States, 99202