CClinicalTrials.gg
CompletedNCT00447551Updated Nov 19, 2019

Canadian Aesthetic Experience With Sculptra Therapy

A Phase 4 interventional study of Poly-L-Lactic Acid in Skin Aging, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Bausch Health Americas, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Aging

Keywords

  • Aesthetic facial volume enhancement
03

In context

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    single group

    Drug: Poly-L-Lactic Acid

Interventions

  • DrugPoly-L-Lactic Acid

    Deep dermal injection

    Also known as: Sculptra

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Document the types and incidence of device adverse events with Sculptra Therapy (Injectable PLLA)

    Time frame: From baseline to 6-months post-Sculptra therapy

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Québec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00447551
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Mar 14, 2007
Start date
Jan 2007
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Nov 19, 2019

Study contacts

Mary Tzortzis
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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