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

NCT02310490 | Completed FDA Device

• 1 other identifier: DermAvance DA-13-007
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Face; Atrophy

Keywords

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator)

  To evaluate the efficacy of treatment versus the comparator in a non-inferiority statistical model using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator

  One Year

Secondary Outcomes (2)

• To evaluate the Global aesthetic improvement as assessed by investigators and subjects

  Two Year

• To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.

  Two Year

Study Arms (2)

Right Side DA-13-007, Left Side Sculptra

ACTIVE COMPARATOR

DA-13-007 right with left side Sculptra left side

Device: DA-13-007 right with left side Sculptra left side

Left Side DA-13-007, Right Side Sculptra

ACTIVE COMPARATOR

DA-13-007 left with Sculptra right side

Device: DA-13-007 left with left side Sculptra right side

Interventions

DA-13-007 right with left side Sculptra left side DEVICE

The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed

Right Side DA-13-007, Left Side Sculptra

DA-13-007 left with left side Sculptra right side DEVICE

The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed

Left Side DA-13-007, Right Side Sculptra

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
• 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.

Sponsors & Collaborators

• DermAvance: lead

Study Sites (4)

Bay Area Dermatology

Bradenton, Florida, 34209, United States

Location

Miami Skin Institute

Coral Gables, Florida, 33146, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

PCR

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Facies; Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• William Werschler, MD

  Premier Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 8, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

US (4)