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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Wrinkles in Decolletage

Intervention / Treatment
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* Device: poly-l-lactic acid (Sculptra)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 8ml<br>Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area | Device: poly-l-lactic acid (Sculptra)<br>* Sculptra<br>|
| Active Comparator: 17ml<br>Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area | Device: poly-l-lactic acid (Sculptra)<br>* Sculptra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders | Percentage of responders, defined by at least one grade improvement from baseline, on the Galderma Decolletage Scale (GDS), as assessed live by the Treating Investigator, at Month 9 | Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of responders | Percentage of responders, defined by at least one grade improvement from baseline, on the GDS, as assessed live by the Treating Investigator, at Month 6 | Month 6 |