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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkles in Decolletage
- Sponsor
- Galderma R&D
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9
Time Frame: 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.
Secondary Outcomes
- Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6(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(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(At Months 6 and 9)