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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sculptra
Galderma Study Site
Encino, California, United States
Galderma Study Site
Solana Beach, California, United States
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.
Time frame: At Month 9
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.
Time frame: 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.
Time frame: 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
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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.
Time frame: At Months 6 and 9