Trials Sponsors Conditions Drugs Pricing

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 sideDevice

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 sideDevice

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

DermAvance
Industrylead

Study Sites (4)

Bay Area Dermatology

Bradenton, Florida, 34209, United States

Miami Skin Institute

Coral Gables, Florida, 33146, United States

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

PCR

Spokane, Washington, 99202, United States

MeSH Terms

Conditions

FaciesAtrophy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

William Werschler, MD
Premier Clinical Research
PRINCIPAL INVESTIGATOR

Enrollment

161 participants (actual enrollment reported by the registry).

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 2015

Actual (reported)

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.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Right Side DA-13-007, Left Side Sculptra

Left Side DA-13-007, Right Side Sculptra

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Right Side DA-13-007, Left Side Sculptra

Left Side DA-13-007, Right Side Sculptra

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations