Clinical trial NCT01916278: Safety and Efficacy Study of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
Official title: A Randomized, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Filler Injections
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-08-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.


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
* Cancerous or precancerous lesions in the area to be treated.
* Immunosuppressive therapy, chemotherapy, treatment with biologics or systemic corticosteroids within 3 months before study treatment.
* Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
* Pregnancy or breast feeding.
* Participation in any other clinical study within 30 days before inclusion.
* Other condition preventing the subject to entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim and chin, subjects anticipated to be unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment result.
* Study site staff or close relatives to study site staff and employees at the sponsor company or close relatives to employees at the sponsor company. Close relatives are defined as parents, children, siblings and spouse.

Primary outcomes:
measure: Lip Fullness Grading Scale (LFGS) score
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
measure: Global Aesthetic Improvement Scale (GAIS)score
timeFrame: 1-12 months
measure: Subject's satisfaction
timeFrame: 0-12 months
measure: Investigator's assessment of treatment procedure
timeFrame: 0-2 weeks
measure: Local tolerability
timeFrame: 14 days
measure: Subject's assessment of treatment pain
timeFrame: 0-2 weeks
measure: Product palpability
timeFrame: 0-2 weeks
measure: Adverse Event reporting
timeFrame: 0-12 months
Locations:
city: Darmstadt
country: Germany
facility: Rosenpark Research
city: Düsseldorf
country: Germany
facility: Medical Skin Center
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
References: