Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile

A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile

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

Study Overview

• Status: Completed
• Conditions: Local Tolerability After Lip Filler Injections
• Intervention / Treatment: Device: Emervel Lips; Device: Juvederm Ultra Smile

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany
    • Medical Skin Center

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emervel Lips	Device: Emervel Lips; Lip treatment of both upper and lower lip
EXPERIMENTAL: Juvederm Ultra Smile	Device: Juvederm Ultra Smile; Lip treatment of both upper and lower lip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tolerability	To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE reporting	To evaluate long-term safety throughout the study period	24 weeks
Global Aesthetic Improvement Scale (GAIS)	To evaluate esthetic change of lips from baseline using GEIS	Week 2 to week 24
Lip Fullness Grading Scale (LFGS)	To evaluate esthetic change of lips from baseline using LFGS	0-24 weeks
Subject's satisfaction	To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire	0-24 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Said Hilton, MD, Medical Skin Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Hyaluronic acid; lip; fillers
• Other Study ID Numbers: 05DF1210