Clinical trial NCT04132518: Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Official title: A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midface Volume Deficit
Keywords: PLLA
Midface Volume Deficit
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator
timeFrame: Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9
measure: Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator
timeFrame: Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12
measure: Total Volume Change From Baseline Over Time of the Right and Left Midface Areas
timeFrame: Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12
measure: Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12
measure: Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12
measure: Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That They Feel More Attractive by the Treatment
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That They Feel Better by the Treatment
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Agreeing That They Are Satisfied by the Treatment
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Who Recommended This Treatment to Their Friends
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
measure: Percentage of Participants Who Liked to Receive the Same Treatment Again
timeFrame: Treatment group: Months 6, 9, 12, 18 and 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Galderma research site 3
city: Beijing
country: China
facility: Galderma research site 4
city: Chengdu
country: China
facility: Galderma research site 5
city: Guangzhou
country: China
facility: Galderma research site 2
city: Hangzhou
country: China
facility: Galderma research site 6
city: Shanghai
country: China
facility: Galderma research site 1
Study officials:
affiliation: Galderma R&D
name: Galderma
role: STUDY_DIRECTOR
References: