Canadian Aesthetic Experience With Sculptra Therapy

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

NCT00447551•Bausch Health Americas, Inc.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+4 more criteria

Locations (1)

Sanofi-Aventis Administrative Office

Québec, Canada

Key Dates

Start Date

January 1, 2007

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

November 19, 2019

Enrollment

ACTUAL participants

Conditions

Skin Aging

Interventions

Poly-L-Lactic Acid

DRUG

MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology

NCT07261748

Aesthetic ProceduresCosmetic Techniques+2 more

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Skin Aging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Canadian Aesthetic Experience With Sculptra Therapy

Inclusion Criteria

Exclusion Criteria

MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology

A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging

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