An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area

Galderma

Status: Completed

Conditions: Wrinkles in Decolletage

Treatments: Device: poly-l-lactic acid (Sculptra)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05538728

43USSA2112

Details and patient eligibility

About

This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.

Full description

A challenge for wrinkle correction of the decolletage/chest and other non-facial areas is that larger surface areas typically need to be treated than for facial indications, for which reason the Sponsor is investigating a larger reconstitution volume compared to the approved label. In this study, the total volume of 18mL, including 1mL of 2% lidocaine, is being explored and compared with results from the current labeled volume of 9mL, including lidocaine, to assess if the larger volume is well-tolerated for treatment for wrinkles in the decolletage area.

Enrollment: 30 patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-pregnant, non-breastfeeding females over the age of 22
• subjects seeking treatment for the décolletage
• subjects with moderate (Grade 2) or severe (Grade 3) on the Galderma Décolletage Scale
• subjects willing to abstain from any other surgical or cosmetic procedures in the décolletage area for the duration of the study.

Exclusion criteria

• Known/previous allergy or hypersensitivity to Sculptra
• Previous tissue augmenting therapy, contouring or revitalization treatment in the décolletage prior to baseline
• Any plastic surgery or permanent surgical implant in the treatment area
• Previous treatment/procedure in the treatment area in the previous 6 months that would interfere with study injections or study assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

8ml

Active Comparator group

Description:

Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area

Treatment:

Device: poly-l-lactic acid (Sculptra)

17ml

Active Comparator group

Description:

Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area

Treatment:

Device: poly-l-lactic acid (Sculptra)