Extension Study for 43USSA1705

Galderma

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: Sculptra Aesthetic, Lidocaine HCL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225273

43USSA1705ext

Details and patient eligibility

About

To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

Enrollment: 38 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705

Exclusion criteria

• Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
• Other condition preventing the subject from entering the study in the Investigator's opinion
• Participation in any interventional clinical study throughout the duration of the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Sculptra Aesthetic

Experimental group

Description:

Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 \[NCT03780244\]). No investigational product was provided during this extension study.

Treatment:

Device: Sculptra Aesthetic, Lidocaine HCL