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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745250
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Q-Med AB

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

Condition or disease Intervention/treatment Phase
Local Tolerability After Lip Filler Injections Device: Emervel Lips Device: Juvederm Ultra Smile Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: Emervel Lips
Emervel Lips
Device: Emervel Lips
Lip treatment of both upper and lower lip

Experimental: Juvederm Ultra Smile
Juvederm Ultra Smile
Device: Juvederm Ultra Smile
Lip treatment of both upper and lower lip

Primary Outcome Measures :
  1. Local tolerability [ Time Frame: 14 days ]
    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 :
  1. AE reporting [ Time Frame: 24 weeks ]
    To evaluate long-term safety throughout the study period

  2. Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Week 2 to week 24 ]
    To evaluate esthetic change of lips from baseline using GEIS

  3. Lip Fullness Grading Scale (LFGS) [ Time Frame: 0-24 weeks ]
    To evaluate esthetic change of lips from baseline using LFGS

  4. Subject's satisfaction [ Time Frame: 0-24 weeks ]
    To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745250

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Medical Skin center
Dusseldorf, Germany
Sponsors and Collaborators
Q-Med AB
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Principal Investigator: Said Hilton, MD Medical Skin Center
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Responsible Party: Q-Med AB Identifier: NCT01745250    
Other Study ID Numbers: 05DF1210
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Q-Med AB:
Hyaluronic acid