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

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

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.

Study Overview

• Status: Completed
• Conditions: Wrinkles in Decolletage
• Intervention / Treatment: Device: poly-l-lactic acid (Sculptra)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Galderma Study Site
    • Solana Beach, California, United States, 92075
      • Galderma Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9	Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.	At Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6	Responder was defined as participants having at least one grade improvement from baseline. GDS was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher score meant very severe lines and wrinkles in the décolletage area.	At Month 6
Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9	Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the participant to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by participant at Months 6 and 9 were reported.	At Month 6 and 9
Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9	Responder was defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS was used by the Treating Investigator to live assess the severity of lines and wrinkles by responding to the question: "Please choose the response below that best describes the overall change in the appearance of your upper chest area since you received the study treatment " by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Months 6 and 9 were reported.	At Months 6 and 9

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Study Director, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 43USSA2112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes