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Canadian Aesthetic Experience With Sculptra Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447551
First Posted: March 14, 2007
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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.


Condition Intervention Phase
Skin Aging Drug: Poly-L-Lactic Acid Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian Study of the Use of Injectable POLY-L-LACTIC Acid (Sculptra Therapy) in Aesthetic Medicine

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. [ Time Frame: From baseline to 6-months post-Sculptra therapy ]

Secondary Outcome Measures:
  • Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA) [ Time Frame: From baseline to 6-months post-Sculptra therapy ]

Enrollment: 76
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group Drug: Poly-L-Lactic Acid
Deep dermal injection
Other Name: Sculptra

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447551


Locations
Canada
Sanofi-Aventis Administrative Office
Québec, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Mary Tzortzis Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00447551     History of Changes
Other Study ID Numbers: POLYL_L_01777
First Submitted: March 13, 2007
First Posted: March 14, 2007
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by Sanofi:
Aesthetic facial volume enhancement