Status:
COMPLETED
Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Lead Sponsor:
Galderma R&D
Conditions:
Midface Volume Deficit
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04132518
Start Date
November 12 2019
End Date
July 18 2022
Last Update
January 7 2025
Active Locations (6)
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1
Galderma research site 3
Beijing, China
2
Galderma research site 4
Beijing, China
3
Galderma research site 5
Chengdu, China
4
Galderma research site 2
Guangzhou, China