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

NCT05538728 | Completed Results FDA Device

• 1 other identifier: 43USSA2112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Wrinkles in Decolletage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

8ml

ACTIVE COMPARATOR

Device: Sculptra current label dilution for treatment of wrinkles in the decolletage area

Device: poly-l-lactic acid (Sculptra)

17ml

ACTIVE COMPARATOR

Experimental: PLLA new dilution volume for treatment of wrinkles in the decolletage area

Device: poly-l-lactic acid (Sculptra)

Interventions

poly-l-lactic acid (Sculptra) DEVICE

Sculptra

17ml; 8ml

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Galderma Study Site

Encino, California, 91436, United States

Location

Galderma Study Site

Solana Beach, California, 92075, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Galderma Research and Development, LLC

aestheticclinicaltrials@galderma.com

817-961-5000

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 14, 2022
• Study Start: August 31, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)