A Randomized, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine

Galderma R&D3 sites in 2 countriesSeptember 2013

ConditionsLip Filler Injections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lip Filler Injections
Sponsor: Galderma R&D
Locations: 3
Primary Endpoint: Lip Fullness Grading Scale (LFGS) score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

May 2015

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female and male subjects aged 18 to 65 years.
•Subjects with the intention to undergo lip augmentation treatment (vermilion mucosa and, if applicable, vermilion borders).
•Subjects with LFGS score of 0 (very thin), 1 (thin) and 2 (moderately thick) (scores may differ between upper and lower lip), and lip appearance judged by the treating investigator to be suitable for optimal correction (≥ 1 grade improvement on the LFGS per lip) with maximum 1.5 mL study product per lip.
•Subjects with signed informed consent.

Exclusion Criteria

•Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \[NSAIDs\]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
•Prior surgery or tattoo to the upper or lower lip or lip line.
•Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator. Tendency to form keloids, hypertrophic scars or any other healing disorders.
•Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, within 12 months before study entry.
•Permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines).
•Previous toxin treatment below the lower orbital rim within 9 months before study entry.
•History of herpes labialis with an outbreak within 4 weeks of study entry or with 4 or more outbreaks in the 12 months before study entry.
•Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
•History of angioedema.
•Known hypersensitivity to HA, lidocaine or other amide-type anaesthetics or history of severe multiple allergies or anaphylactic shock