CompletedNCT03289052Updated May 12, 2023Results posted

Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

An interventional study of Restylane Volyme in Midface Volume Deficit, sponsored by Galderma R&D. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 168
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Midface Volume Deficit

Keywords

Hyaluronic acid, midface

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Signed informed consent
Men or women aged 18 years of age or older of Chinese origin
Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
Subjects 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

Exclusion Criteria:

Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
Previous surgery 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 below the level of the lower orbital rim.
Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 9 months before treatment.
Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
Other condition preventing the subject from entering the study in the Investigator's opinion.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 168 participants (actual)

Study arms

Experimental
Restylane Volyme
Single injection and optional touch up injection with Restylane Volyme in Midface
Device: Restylane Volyme
No intervention
No intervention arm
No treatment

Interventions

DeviceRestylane Volyme
Subcutis injection

What researchers measure

Primary outcomes

Percentage of Responders
Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.
Time frame: 6 month

Results

Posted Mar 15, 2021

Participant flow

Participant flow — Overall Study
Milestone	Group A	Group B-Restylane Volyme Treatment Arm	Group B- Control Arm
Started	20	111	37
Completed	20	108	32
Not completed	0	3	5

Outcome measures

PrimaryPercentage of Responders

Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.

Time frame:: 6 month
Reported as:: Number · percentage of subjects

Percentage of Responders
percentage of subjects	Group A	Group B-treatment Arm	Group B-control Arm
Percentage of Responders	80 (56.3 to 94.3)	87.2 (79.4 to 92.8)	76.7 (57.7 to 90.1)

Adverse events

Collected over 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	0/20 (0%)	1/20 (5%)	0/20 (0%)
Group B-treatment Arm	0/111 (0%)	1/111 (0.9%)	0/111 (0%)
Group B-control Arm	0/37 (0%)	0/37 (0%)	0/37 (0%)

Most frequent serious events

Most frequent serious events
Event	Group A	Group B-treatment Arm	Group B-control Arm
Lung adenocarcinoma stage 0Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1/20	0/111	0/37
Skin papillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/20	1/111	0/37

Baseline characteristics

All summaries will be done separately for Group A (20subjects) and B(148 subjects). For statistical inference, only Group B will be used.

Age, Categorical
Age, Categorical(Participants)	Group A	Restylane Volyme Treatment Group of Group B	Control Group of Group B	Total
<=18 years	0	0	0	0
Between 18 and 65 years	20	109	37	166
>=65 years	0	2	0	2

Age, Continuous
Age, Continuous(years)	Group A	Restylane Volyme Treatment Group of Group B	Control Group of Group B	Total
Mean	46.3 ± 9.7	41.3 ± 10.2	41.2 ± 10.0	41.3 ± 10.1

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Restylane Volyme Treatment Group of Group B	Control Group of Group B	Total
Female	20	104	32	156
Male	0	7	5	12

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A	Restylane Volyme Treatment Group of Group B	Control Group of Group B	Total
Chinese Han	20	111	37	168

Region of Enrollment
Region of Enrollment(participants)	Group A	Restylane Volyme Treatment Group of Group B	Control Group of Group B	Total
China	20	111	37	168

Study locations

1 site

Q-Med AB
Shanghai, China

References and documents

Study documents

Study protocol · Dec 9, 2022
Statistical analysis plan · Dec 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03289052
Lead sponsor: Galderma R&D
Responsible party: Sponsor
First posted: Sep 20, 2017
Start date: Dec 1, 2017
Primary completion: Jan 31, 2019
Completion: Jul 31, 2019
Results posted: Mar 15, 2021
Last update: May 12, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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