CompletedNot Applicable

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

China205 participantsStarted 2019-11-12

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT04132518

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-18

Results submitted2022-10-10

View on ClinicalTrials.gov More Midface Volume Deficit trials