Canadian Aesthetic Experience With Sculptra Therapy

Canadian Study of the Use of Injectable POLY-L-LACTIC Acid (Sculptra Therapy) in Aesthetic Medicine

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Drug: Poly-L-Lactic Acid

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single group	Drug: Poly-L-Lactic Acid; Deep dermal injection; Other Names: Sculptra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the degree of correction attainable with Sculptra (injectable PLLA) for the correction of nasolabial folds, mid-and lower facial volume loss, jawline laxicity, and other signs of facial aging.	From baseline to 6-months post-Sculptra therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA)	From baseline to 6-months post-Sculptra therapy

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Mary Tzortzis, Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 13, 2007
• First Submitted That Met QC Criteria: March 13, 2007
• First Posted (Estimate): March 14, 2007

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Aesthetic facial volume enhancement
• Other Study ID Numbers: POLYL_L_01777