Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

NCT04132518 | Completed Results

• 1 other identifier: 43CHSA1803
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 6

Brief Summary

This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.

Conditions

Midface Volume Deficit

Keywords

PLLA; Midface Volume Deficit

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12

  MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

  Baseline, Month 12

Secondary Outcomes (15)

• Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator

  Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9

• Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator

  Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12

• Total Volume Change From Baseline Over Time of the Right and Left Midface Areas

  Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12

• Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator

  Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12

• Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant

  Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12

Study Arms (3)

Group A: Sculptra

EXPERIMENTAL

Participants in Group A will receive up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and will be followed up for 24 months.

Device: Sculptra

Group B: Sculptra

EXPERIMENTAL

Participants in Group B will receive up to 4 injections of Sculptra from Day 1 with 5 (±1) weeks (at least 4 weeks) intervals and will be followed up for 24 months.

Device: Sculptra

Group B: Control

NO INTERVENTION

Participants in Group B will not receive any treatment and participants will be followed up for 12 months.

Interventions

Sculptra DEVICE

Initial injection and optional 3 injections with Sculptra in Midface.

Group A: Sculptra; Group B: Sculptra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent to participate in the study.
• Men or women aged 18 years of age or older of Chinese origin.
• Participants seeking augmentation therapy for the midface.
• MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.

You may not qualify if:

• Known/previous allergy or hypersensitivity to any of the constituents of the product.
• Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
• History of severe or multiple allergies, such as anaphylaxis.
• Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the area to be treated within 6 months before treatment.
• Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
• Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant in the area to be treated.
• Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. participants not likely to avoid other facial cosmetic treatments, participants anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Galderma research site 3

Beijing, China

Location

Galderma research site 4

Beijing, China

Location

Galderma research site 5

Chengdu, China

Location

Galderma research site 2

Guangzhou, China

Location

Galderma research site 6

Hangzhou, China

Location

Galderma research site 1

Shanghai, China

Location

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Study Officials

• Galderma

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: November 12, 2019
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2022
• Last Updated: January 7, 2025
• Results First Posted: December 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)