CompletedNot Applicable

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

China168 participantsStarted 2017-12-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Percentage of Responders

Timeframe: 6 month

NCT IDNCT03289052

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-31

Results submitted2020-11-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.