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

Galderma

Status: Completed

Conditions: Midface Volume Deficit

Treatments: Device: Sculptra

Study type: Interventional

Funder types: Industry

Identifiers

NCT04132518

43CHSA1803

Details and patient eligibility

About

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

Full 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.

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 3 patient groups

Group A: Sculptra

Experimental group

Description:

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.

Treatment:

Device: Sculptra

Group B: Sculptra

Experimental group

Description:

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.

Treatment:

Device: Sculptra

Group B: Control

No Intervention group

Description:

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