Clinical trial NCT01745250: Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
Official title: A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Tolerability After Lip Filler Injections
Keywords: lip
fillers
Hyaluronic acid
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile


Eligibility criteria: Inclusion Criteria:

* Female subjects aged 18 to 65 years.
* Subjects with the intention to undergo lip augmentation treatment.
* Subjects treatment-naïve for lip augmentation treatment
* Subjects with lip appearance judged by the treating investigator to be suitable for lip line treatment
* 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.
* Previous tissue augmenting therapy in the lip area (including oral commissures, 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 area surrounding the lips (including nasolabial folds, oral commissures, marionette and perioral lines).
* 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.
* Previous hypersensitivity to HA.
* Previous hypersensitivity to lidocaine or other amide-type anaesthetics
* 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.
* 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, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
* Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).

Primary outcomes:
measure: Local tolerability
timeFrame: 14 days
Secondary outcomes:
measure: AE reporting
timeFrame: 24 weeks
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: Week 2 to week 24
measure: Lip Fullness Grading Scale (LFGS)
timeFrame: 0-24 weeks
measure: Subject's satisfaction
timeFrame: 0-24 weeks
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Medical Skin center
Study officials:
affiliation: Medical Skin Center
name: Said Hilton, MD
role: PRINCIPAL_INVESTIGATOR
References: