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This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Single injection and optional touch-up injection with Restylane Defyne in chin |
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| Control Group | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Defyne | Device | Intradermal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method. | At Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Q-Med AB | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38315229 | Derived | Xie Y, Zhao H, Wu W, Xu J, Li B, Wu S, Chen K, Bromee T, Li Q. Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study. Aesthetic Plast Surg. 2024 Mar;48(5):1030-1036. doi: 10.1007/s00266-023-03812-2. Epub 2024 Feb 5. |
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The study was conducted at 5 sites in China from 08 Oct 2018 to 09 Sep 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Defyne (Treatment Group) | Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. |
| FG001 | Control (No Treatment Then Restylane Defyne) | Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full Analysis Set (FAS) included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Defyne (Treatment Group) | Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. |
| Units | Counts |
|---|---|
| Participants |
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| 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 (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method. | FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 |
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From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
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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 | Restylane Defyne (Treatment Group) | Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal liver function | Hepatobiliary disorders | MedDRA (21.0) | Non-systematic Assessment | Abnormal liver function was unrelated to the injection procedure and/or the study product. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment | Upper respiratory tract infection was not related to the injection procedure and/or the study product. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2018 | Sep 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2018 | Sep 15, 2023 | SAP_001.pdf |
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| Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment |
| Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6. | At Week 4 and Months 3, and 6 |
| Could not return for treatment |
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| Moved from location |
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| Not accepted the treatment |
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| BG001 | Control (No Treatment Then Restylane Defyne) | Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Blinded Evaluator Galderma Chin Retrusion Scale | Galderma Chin Retrusion Scale (GCRS) is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". | Count of Participants | Participants |
|
| Restylane Defyne (Treatment Group) |
Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. |
| OG001 | Control (No Treatment Then Restylane Defyne) | Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. |
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| Secondary | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases. | FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, "number of overall participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment |
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| Secondary | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6. | FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, "number of overall participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 4 and Months 3, and 6 |
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| 0 |
| 111 |
| 2 |
| 111 |
| 19 |
| 111 |
| EG001 | Control (No Treatment) | Participants did not receive treatment at baseline and month 6 follow up visit. | 0 | 37 | 1 | 37 | 4 | 37 |
| EG002 | Control (Restylane Defyne) | Participants received initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. | 0 | 34 | 1 | 34 | 5 | 34 |
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| Cervical squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment | Cervical squamous cell carcinoma was unrelated to the injection procedure and/or the study product. |
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| Uterine subserosal leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Non-systematic Assessment | Uterine subserosal leiomyoma was unrelated to the injection procedure and/or the study product. |
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| Lumbar disc herniation | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment | Lumbar disc herniation was unrelated to the product and/or injection procedure. |
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Initial publication of data from Study must be a multi-centre publication. Any subsequent publication/presentation must be sent to Sponsor for review 60 days before submission for publication/presentation to allow Sponsor to protect patentable inventions/confidential information. Site and Investigator agree to amend proposed publication/presentation, remove such confidential information from it, or postpone submission for a further 60 days/until intellectual property filings take place.
| Month 6 (after last treatment) |
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| Month 9 (after last treatment) |
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| Month 12 (after last treatment) |
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| Month 3 (after randomization) |
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| At Month 3 |
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| At Month 6 |
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