Canadian Aesthetic Experience With Sculptra Therapy

NCT ID: NCT00447551

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-04-30

Brief Summary

Primary objective To evaluate the degree of correction achievable with Sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing.

To document the types and incidence of device-related adverse events with Sculptra.

Conditions

Skin Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single group

Group Type: EXPERIMENTAL

Poly-L-Lactic Acid

Intervention Type: DRUG

Deep dermal injection

Interventions

Poly-L-Lactic Acid

Deep dermal injection

Intervention Type: DRUG

Other Intervention Names

Sculptra

Eligibility Criteria

Inclusion Criteria

• Present with nasolabial folds, mid- and lower facial volume loss, jawline laxity or other signs of facial ageing to be treated with Sculptra
• The subject must be willing and able to provide written informed consent that includes a release for use of their photographs in publications. Subjects who refuse the photo release will not be eligible to participate in the study.
• Female subjects must be post-menopausal for at least one year or have had a hysterectomy or tubal ligation; if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device (IUD), or spermicide in combination with a barrier method of contraception);

Exclusion Criteria

• Personal history of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine);
• Known history of bleeding disorders;
• Active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease);
• Active hepatitis within the past year;
• Subjects who are pregnant or who plan to become pregnant within the study timeframe, or who are breastfeeding;
• HIV positive patients;
• Recent history of trauma in the face (< 1 year);
• Previous use of Dermalive or Dermadeep;
• Previous facial surgery within the last six months;
• Recent facial filler within the last six months;
• Planned surgical interventions (such as rhinoplasty, facelift, congenital defect repair) or use of other fillers or lasers for the initial six months post-Sculptra therapy;
• Subjects with clinically important disease as judged by the investigator within 3 months of the start of the study (e.g., history of significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue disease, etc.), including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (severe asthma, rheumatoid arthritis, organ transplant, etc.);
• Subjects who have used superficial dermal resurfacing procedures in the facial area, including chemical peel, dermabrasion, or microderm treatments within six weeks of visit 1 and for the duration of the main study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Tzortzis

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Québec, , Canada

Countries

Canada

Other Identifiers

POLYL_L_01777

Identifier Type: -

Identifier Source: org_study_id