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

Galderma R&D205 enrolled

Overview

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

For Group A, after screening, eligible participants will be treated from day 1 and followed up for 24 months. The purpose of Group A was to confirm investigator's use of correct injection technique. For Group B, the study includes two phases as follows: Main study phase: It is randomized, evaluator-blinded and no-treatment controlled. After screening, all eligible participants will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the participants will be followed up for 12 months. Extension study phase: After the main study phase, the Treatment Group will be followed up for additional 12 months. Each subject assigned to Group A and Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals. Participants assigned to the Control Group will not receive treatment during the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

205

Conditions

Midface Volume Deficit

Interventions

SculptraDEVICE

Initial injection and optional 3 injections with Sculptra in Midface.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed and dated informed consent to participate in the study. 2. Men or women aged 18 years of age or older of Chinese origin. 3. Participants seeking augmentation therapy for the midface. 4. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator. Exclusion Criteria: 1. Known/previous allergy or hypersensitivity to any of the constituents of the product. 2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics. 3. History of severe or multiple allergies, such as anaphylaxis. 4. 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. 5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated. 6. 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. 7. 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.

Locations (6)

Galderma research site 3

Beijing, China

Galderma research site 4

Beijing, China

Galderma research site 5

Chengdu, China

Galderma research site 2

Guangzhou, China

Outcomes

Primary Outcomes

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

Time frame: Baseline, Month 12

Secondary Outcomes

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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Galderma research site 6

Galderma research site 1

Shanghai, China

Time frame: 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

Total volume change from baseline over time (both sides of the face combined) was calculated by a digital 3D image analysis.

Time frame: 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

The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description:1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Treating Investigator was reported.

Time frame: 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

The 5-graded GAIS was used to live assess the aesthetic improvement of the midface fullness of both sides of the participant's face as compared to photographs taken before treatment. Each midface side was rated separately. Rating and its Description: 1. Very much improved (Optimal cosmetic result for the implant in this participant), 2. Much improved (Marked improvement in appearance from the original condition),3. Improved (Obvious improvement in appearance from the original condition), 4. No change (The appearance is essentially the same as original condition), 5. Worse (The appearance is worse than the original condition). Responders are those with a rating of at least improved. Participants with a GAIS rating of 'Very much improved', 'Much improved', or 'Improved' are defined as responders. Percentage of responders," according to the GAIS on both sides of the face combined, as assessed by the Participant was reported.

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

Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment

The subject's satisfaction with the procedure was assessed using a Subject Satisfaction Questionnaire. Question 1 was a YES or NO question pertaining to satisfaction with study treatment: Do you think your Cheek Volume deficit and/or Contour Deficiency has been improved with the treatment?