N/A
N=205
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Midface Volume Deficit
Bottom Line
View on ClinicalTrials.gov: NCT04132518 ↗Enrolled (actual)
205
Serious AEs
4.4%
Results posted
Dec 2024
Primary outcome: Primary: 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 — 68.8; 69.4; 1.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sculptra (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
68.8; 69.4; 1.6 | — |
| SECONDARY Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator |
81.3; 68.5; 3.2; 62.5; 68.0; 3.2 | — |
| SECONDARY Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator |
93.8; 81.5; 6.5; 93.8; 80.3; 4.8 | — |
| SECONDARY Total Volume Change From Baseline Over Time of the Right and Left Midface Areas |
2.15; 1.96; 0.15; 2.63; 2.46; 0.13 | — |
| SECONDARY Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator |
100.0; 97.6; 3.2; 93.8; 98.4; 1.6 | — |
| SECONDARY Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant |
100.0; 96.0; 1.6; 93.8; 95.9; 0.0 | — |
| SECONDARY Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment |
93.8; 93.5; 93.8; 95.9; 93.8; 94.3 | — |
| SECONDARY Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural |
100.0; 98.4; 100.0; 97.5; 93.8; 98.4 | — |
| SECONDARY Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment |
62.5; 69.4; 31.3; 12.9; 62.5; 75.4 | — |
| SECONDARY Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence" |
87.5; 58.1; 31.3; 29.8; 50.0; 41.1 | — |
| SECONDARY Percentage of Participants Agreeing That They Feel More Attractive by the Treatment |
100.0; 80.6; 93.8; 85.2; 93.8; 86.9 | — |
| SECONDARY Percentage of Participants Agreeing That They Feel Better by the Treatment |
50.0; 15.3; 12.5; 47.6; 37.5; 34.7 | — |
| SECONDARY Percentage of Participants Agreeing That They Are Satisfied by the Treatment |
6.3; 19.4; 43.8; 49.2; 50.0; 29.8 | — |
| SECONDARY Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues |
81.3; 71.0; 81.3; 68.9; 81.3; 77.9 | — |
| SECONDARY Percentage of Participants Who Recommended This Treatment to Their Friends |
100.0; 90.3; 100.0; 90.2; 93.8; 87.7 | — |
| SECONDARY Percentage of Participants Who Liked to Receive the Same Treatment Again |
100.0; 85.5; 100.0; 82.8; 93.8; 83.6 | — |
Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04132518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.