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This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM® VOLBELLA® XC with Lidocaine | Experimental | JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable. |
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| No-treatment Control | Experimental | No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM® VOLBELLA® XC with Lidocaine | Device | JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS) | 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. | Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smita Chawla | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Southern Theatre Command | Guangzhou | Guangdong | 510010 | China | ||
| Nanfang Hospital, Southern Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36387967 | Derived | Li D, Gao Z, Sun J, Li Q, Jiang P, Zhang L, Chawla S. Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults. Clin Cosmet Investig Dermatol. 2022 Nov 10;15:2427-2436. doi: 10.2147/CCID.S382194. eCollection 2022. |
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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Three participants were randomized to the no-treatment control group but were treated in error on the day of randomization and were included in the treatment group for the Modified-intent-to-treat (mITT) population and the Safety population for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-treatment Control | No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment. |
| FG001 | JUVÉDERM® VOLBELLA® XC With Lidocaine | JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.
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| ID | Title | Description |
|---|---|---|
| BG000 | No-treatment Control | No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS) | 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. | mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
Baseline up to Month 12 Post Treatment
Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. 29 participants in the No-treatment Control arm received JUVÉDERM® VOLBELLA® XC with Lidocaine after 3 months and are included in the JUVÉDERM® VOLBELLA® XC with Lidocaine arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No-treatment Control (Control Period) | No-treatment was administered during control period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site ischaemia | General disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2018 | Mar 28, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 29, 2015 | Mar 28, 2019 | Prot_001.pdf |
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| No-treatment Control | Other | No-treatment was administered. |
|
| Baseline to Month 3 Post Treatment |
| Change From Baseline in Overall Lip Volume | 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. | Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
| Percentage Change From Baseline in Lip Surface Area | 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. | Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
| Procedural Pain Score | 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. | Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine |
| Number of Participants With Injection Site Responses (ISRs) | 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. | Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Baseline to Month 12 Post Treatment |
| Guangzhou |
| Guangdong |
| 510515 |
| China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
| China-Japan Friendship Hospital | Beijing | 100029 | China |
| Peking University Third Hospital | Beijing | 100083 | China |
| Other Miscellaneous Reasons |
|
| JUVÉDERM® VOLBELLA® XC With Lidocaine |
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Lip Fullness Scale (LFS) Score as Assessed by Evaluating Investigator (EI) | The investigator assessed the participant's lip fullness using a 5-point scale 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). | mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | No-treatment Control | No-treatment was administered during control period. |
| OG001 | JUVÉDERM® VOLBELLA® XC With Lidocaine | JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable. |
|
|
|
| Secondary | Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS | 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. | mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of the primary variable. As per protocol, analysis for this Outcome Measure was for the Treatment arm only. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Month 3 Post Treatment |
|
|
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| Secondary | Change From Baseline in Overall Lip Volume | 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. | mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable. | Posted | Median | Full Range | cubic centimeters (cc) | Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
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|
|
|
| Secondary | Percentage Change From Baseline in Lip Surface Area | 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. | mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable. | Posted | Median | Full Range | percentage change in lip surface area | Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) |
|
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|
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| Secondary | Procedural Pain Score | 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. | Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA®. | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine |
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| Secondary | Number of Participants With Injection Site Responses (ISRs) | 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. | Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA® XC with Lidocaine. | Posted | Count of Participants | Participants | Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. | Posted | Count of Participants | Participants | Baseline to Month 12 Post Treatment |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | JUVÉDERM® VOLBELLA® XC With Lidocaine (All Treated) | JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable. Includes 29 participants in the No-treatment Control arm who received treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine injected into lips after 3 months. | 0 | 165 | 5 | 165 | 40 | 165 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Touch-up Treatment |
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