DA-13-007 Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles

Completed · Not applicable

Conditions studied: Face; Atrophy

In brief

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 nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007l and SCULPTRA on either the right or left side of the face.

Key facts

Study ID

NCT02310490

Run by

DermAvance

People needed

161

Starts

2015-01-01

Expected to finish

2018-12-01

Last updated by the study team

2024-08-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Committed to abstain from procedures interfering with the treatment outcome (exclusion criteria) throughout the study.
• Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.

You may not qualify if…

• 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.

Where it is running

• Bay Area Dermatology — Bradenton, Florida, United States
• Miami Skin Institute — Coral Gables, Florida, United States
• Laser & Skin Surgery Center of Indiana — Carmel, Indiana, United States
• PCR — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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