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Completed

NCT Number: NCT03519204

Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.

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Key information

Conditions

Lip Enhancement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Southern Theatre Command, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.
  • Has the ability to follow study instructions and is likely to complete all required visits

Exclusion criteria

  • Has had any facial procedures or trauma that may interfere with the study procedures and results
  • Is on anti-coagulation therapy or other contraindicated treatments
  • Has current cutaneous inflammatory or infectious processes or lesions in the mouth area

Treatment and study plan

JUVÉDERM® VOLBELLA® XC with Lidocaine

Device

JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.

No-treatment control

Other

No-treatment was administered.

Primary outcomes

  1. Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)

    Time frame: Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)

    The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

Secondary outcomes

  1. Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS

    Time frame: Baseline to Month 3 Post Treatment

    Lip fullness was assessed by the participant using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

  2. Change From Baseline in Overall Lip Volume

    Time frame: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)

    Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

  3. Percentage Change From Baseline in Lip Surface Area

    Time frame: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)

    Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

  4. Procedural Pain Score

    Time frame: Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine

    Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis.

  5. Number of Participants With Injection Site Responses (ISRs)

    Time frame: Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine

    ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis.

  6. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline to Month 12 Post Treatment

    An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 8, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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