Clinical trial NCT05538728: An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles in Decolletage
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Responders on the Galderma Décolletage Scale (GDS), as Assessed Live by the Treating Investigator, at Month 9
timeFrame: At Month 9
Secondary outcomes:
measure: Percentage of Responders on the Galderma Décolletage Scale, as Assessed Live by the Treating Investigator, at Month 6
timeFrame: At Month 6
measure: Percentage of Responders Who Achieved At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant at Months 6 and 9
timeFrame: At Month 6 and 9
measure: Percentage of Responders With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Months 6 and 9
timeFrame: At Months 6 and 9
Other outcomes:
Locations:
city: Encino
country: United States
facility: Galderma Study Site
state: California
city: Solana Beach
country: United States
facility: Galderma Study Site
state: California
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: