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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-08-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wrinkles in Decolletage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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8ml

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

Group Type ACTIVE_COMPARATOR

poly-l-lactic acid (Sculptra)

Intervention Type DEVICE

Sculptra

17ml

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

Group Type ACTIVE_COMPARATOR

poly-l-lactic acid (Sculptra)

Intervention Type DEVICE

Sculptra

Interventions

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poly-l-lactic acid (Sculptra)

Sculptra

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes