Safety and Efficacy Study of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine

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

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.

Study Overview

• Status: Completed
• Conditions: Lip Filler Injections
• Intervention / Treatment: Device: Emervel Lips Lidocaine; Device: Juvéderma Volbella with Lidocaine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany, 64283
    • Rosenpark Research
  • Düsseldorf, Germany
    • Medical Skin Center
• Sweden
  • Stockholm, Sweden, 115 42
    • Akademikliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emervel Lips Lidocaine	Device: Emervel Lips Lidocaine
EXPERIMENTAL: Juvéderm Volbella with Lidocaine	Device: Juvéderma Volbella with Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lip Fullness Grading Scale (LFGS) score	To evaluate esthetic change of lips from baseline using LFGS	0-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Aesthetic Improvement Scale (GAIS)score	To evaluate esthetic change of lips from baseline using GAIS	1-12 months
Subject's satisfaction	To evaluate subject's satisfaction in terms of a subject satisfaction questionnaire	0-12 months
Investigator's assessment of treatment procedure	To evaluate the ease of injection and moulding	0-2 weeks
Local tolerability	To assess local tolerability after treatment including bruising, redness, swelling, pain, tenderness and itching at 14 days. Local tolerability ongoing 2 weeks after treatment will be recorded as an AE and continued follow-up.	14 days
Subject's assessment of treatment pain	To evaluate subject's experience of pain during treatment.	0-2 weeks
Product palpability	To evaluate if study product is palpable or not palpable. If assessed as palpable, also to evaluate if the feel is expected/normal or unexpected/abnormal. Unexpected feel of palpable product present 2 weeks after treatment will be recorded as an AE and continued follow-up.	0-2 weeks
Adverse Event reporting	To evaluate long-term safety throughout the study period	0-12 months

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (ESTIMATE): August 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 05DF1215