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

NCT ID: NCT01745250

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-07-31

Brief Summary

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

Conditions

Local Tolerability After Lip Filler Injections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Emervel Lips

Emervel Lips

Group Type: EXPERIMENTAL

Emervel Lips

Intervention Type: DEVICE

Lip treatment of both upper and lower lip

Juvederm Ultra Smile

Juvederm Ultra Smile

Group Type: EXPERIMENTAL

Juvederm Ultra Smile

Intervention Type: DEVICE

Lip treatment of both upper and lower lip

Interventions

Emervel Lips

Lip treatment of both upper and lower lip

Intervention Type: DEVICE

Juvederm Ultra Smile

Lip treatment of both upper and lower lip

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Said Hilton, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Skin Center

Locations

Medical Skin center

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

05DF1210

Identifier Type: -

Identifier Source: org_study_id