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

Not Applicable

Completed

Conditions: Wrinkles in Decolletage

Interventions: Device: poly-l-lactic acid (Sculptra)

Registration Number: NCT05538728

Lead Sponsor: Galderma R&D

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 30

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8ml	poly-l-lactic acid (Sculptra)	Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area
17ml	poly-l-lactic acid (Sculptra)	Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area

Primary Outcome Measures

Name	Time	Method
Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9	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 Outcome Measures

Name	Time	Method
Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6	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.
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	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.
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	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.