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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01745250
First received: December 4, 2012
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Local Tolerability After Lip Filler Injections
Device: Emervel Lips
Device: Juvederm Ultra Smile

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Local tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • AE reporting [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To evaluate long-term safety throughout the study period

  • Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Week 2 to week 24 ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline using GEIS

  • Lip Fullness Grading Scale (LFGS) [ Time Frame: 0-24 weeks ] [ Designated as safety issue: No ]
    To evaluate esthetic change of lips from baseline using LFGS

  • Subject's satisfaction [ Time Frame: 0-24 weeks ] [ Designated as safety issue: No ]
    To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emervel Lips
Emervel Lips
Device: Emervel Lips
Lip treatment of both upper and lower lip
Other Name: Emervel Lips
Experimental: Juvederm Ultra Smile
Juvederm Ultra Smile
Device: Juvederm Ultra Smile
Lip treatment of both upper and lower lip
Other Name: Juvederm Ultra Smile

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745250

Locations
Germany
Medical Skin center
Dusseldorf, Germany
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Said Hilton, MD Medical Skin Center
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01745250     History of Changes
Other Study ID Numbers: 05DF1210
Study First Received: December 4, 2012
Last Updated: May 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Q-Med AB:
lip
fillers
Hyaluronic acid

ClinicalTrials.gov processed this record on September 18, 2014