Canadian Aesthetic Experience With Sculptra Therapy - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00447551

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 IV

MedlinePlus related topics: Skin Aging

Drug Information available for: Lactic acid Ammonium lactate Poly-L-lactic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Canadian Study of the Use of Injectable POLY-L-LACTIC Acid (Sculptra Therapy) in Aesthetic Medicine

Further study details as provided by Sanofi-Aventis:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	January 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single group: Experimental	Drug: Poly-L-Lactic Acid Deep dermal injection

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447551

Locations

Canada
Sanofi-Aventis
Laval, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Mary Tzortzis

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	POLYL_L_01777
Study First Received:	March 13, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00447551
Health Authority:	Canada: Health Canada

Keywords provided by Sanofi-Aventis:

Aesthetic facial volume enhancement

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on January 16, 2009