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This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Down-up | Experimental | Participants in this group received up to 2 mL Restylane Defyne on chin at baseline and up to 2 mL of Restylane Defyne per NLF at baseline and up to 2 mL per ML of Restylane Defyne at Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. |
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| Top-down | Experimental | Participants in this group received up to 2 mL Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at baseline and up to 2mL on chin Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Defyne | Device | Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported. | At Week 3 |
| Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported. | At Week 6 |
| Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: "The treatment results were natural looking". The investigator's questionnaire for naturalness of the treatment result were categorized into "strongly agree, agree, neither agree or disagree, disagree and strongly disagree". The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Birmingham | Alabama | 35209 | United States | ||
| Galderma Research Site |
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The study was conducted at 2 sites each in Brazil and Unites States,1 site in Italy from 07 Dec 2020 to 15 Sept 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Down-up | Participants in this group received injections in the chin and surrounding area with up to 2 milliliters (mL) Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the nasolabial folds (NLFs) and marionette lines (MLs) with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
| FG001 | Top-down | Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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MITT population included all participants who were treated at both baseline and week 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Down-up | Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
| 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 | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported. | MITT population included all participants who were treated at both Baseline and Week 3. | Posted | Count of Participants | Participants | At Week 3 |
From start of the study drug administration up to Week 9
Safety population was defined as all participants who were injected with study product.
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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 | Down-up | Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site bruising | General disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2020 | Apr 6, 2023 | Prot_SAP_001.pdf |
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| Restylane Defyne | Device | Up to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6. |
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Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.
| At Week 9 |
| At Week 3, 6, and 9 |
| Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported. | At Week 3, 6 and 9 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Galderma Research Site | Belo Horizonte | Brazil |
| Galderma Research Site | São Paulo | Brazil |
| Galderma Research Site | Palermo | Italy |
| Not Treated |
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| BG001 | Top-down | Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Fitzpatrick Skin Types | Fitzpatrick Skin Type is a numerical classification scale for the color of skin from Type I to Type VI. Type I= always burns, never tans, Type II= usually burns, tans minimally (light colored but darker than fair), Type III= sometimes mild burn, tans uniformly (golden honey or olive), Type IV= burns minimally, always tan well (moderate brown), Type V= very rarely burns, tans very easily (dark brown), Type VI= never burns (deeply pigmented dark brown to darkest brown). | Count of Participants | Participants |
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| ID | Title | Description |
|---|
| OG000 | Down-up | Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
| OG001 | Top-down | Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. |
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| Primary | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported. | MITT population included all participants who were treated at both Baseline and Week 3. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | At Week 6 |
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| Primary | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported. | MITT population included all participants who were treated at both Baseline and Week 3. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | At Week 9 |
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| Secondary | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: "The treatment results were natural looking". The investigator's questionnaire for naturalness of the treatment result were categorized into "strongly agree, agree, neither agree or disagree, disagree and strongly disagree". The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported. | MITT population included all participants who were treated at both Baseline and Week 3. Here, "number analyzed" signifies participants who were evaluable for this outcome measure at specified timepoints. | Posted | Number | Percentage of participants | At Week 3, 6, and 9 |
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| Secondary | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported. | MITT population included all participants who were treated at both Baseline and Week 3. Here, "number analyzed" signifies participants who were evaluable for this outcome measure at specified timepoints. | Posted | Number | Percentage of participants | At Week 3, 6 and 9 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 7 |
| 32 |
| EG001 | Top-down | Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. | 0 | 29 | 0 | 29 | 5 | 29 |
| Implant Site Pain | General disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Implant site swelling | General disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
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| Lip injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
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| Improved |
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| Improved |
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| Naturalness at Week 3: Agree |
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| Naturalness at Week 6: Strongly agree |
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| Naturalness at Week 6: Agree |
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| Naturalness at Week 9: Strongly agree |
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| Naturalness at Week 9: Agree |
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| My first treatment improved my appearance at Week 6 |
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| My first treatment improved my appearance at Week 9 |
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| I am satisfied with the contour of my lower face after treatment at Week 3 |
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| I am satisfied with the contour of my lower face after treatment at Week 6 |
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| I am satisfied with the contour of my lower face after treatment at Week 9 |
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| I am satisfied with how well-defined my chin looks at Week 3 |
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| I am satisfied with how well-defined my chin looks at Week 6 |
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| I am satisfied with how well-defined my chin looks at Week 9 |
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| I feel more attractive after treatment at Week 3 |
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| I feel more attractive after treatment at Week 6 |
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| I feel more attractive after treatment at Week 9 |
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| I feel comfortable being photographed at Week 3 |
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| I feel comfortable being photographed at Week 6 |
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| I feel comfortable being photographed at Week 9 |
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| Compared to my first treatment, treating both areas in combination improved my appearance at Week 6 |
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| Compared to my first treatment, treating both areas in combination improved my appearance at Week 9 |
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| I am satisfied with the shape of my chin at Week 3 |
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| I am satisfied with the shape of my chin at Week 6 |
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| I am satisfied with the shape of my chin at Week 9 |
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