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This study is designed to evaluate effectiveness and safety of GP0109 for Jawline definition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment of Jawline |
|
| No treatment Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP0109 | Device | Treatment of the Jawline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS) | The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently. | At Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (Site#8784) | San Juan | 00917 | Puerto Rico |
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A total of 245 participants were screened for the study, of which 21 were screen failures. Of the 224 randomized participants, 56 were randomly assigned to the no treatment group and 168 were randomly assigned to receive GP0109 injection at baseline stratified by injection tool (needle, cannula and both needle and cannula combined) and Fitzpatrick skin type (FST) group (I-III, IV and V-VI).
This study was conducted at 15 investigative sites in the United States from 15 November 2021 to 23 October 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: No Treatment Control Group | Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109. |
| FG001 | Group 2: Treatment With GP0109 | Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: No Treatment Control Group | Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109. |
| BG001 | Group 2: Treatment With GP0109 |
| 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 Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS) | The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently. | The Intention-to-treat (ITT) population includes all participants who were randomized and analyzed according to the randomization scheme. All effectiveness variables were analyzed based on the ITT population. The modified Baseline Observation Carried Forward (BOCF) method was used. | Posted | Number | percentage of participants | At Month 3 |
|
For Group 1: From baseline up to Month 12; For Group 2: From baseline (day 1 of treatment) up to 24 months of the study and for Group 3: From Month 12 to Month 24
Safety population: Participants treated with GP0109 or randomized to no treatment at baseline. As pre-specified in statistical analysis plan, Group 2: Initial Treatment included pooled AEs before Month12 re-treatment or through end of study if no re-treatment for participants treated with GP0109 at baseline and AEs after initial GP0109 treatment at Month 12 for participants with no treatment at baseline. Death reported in Group 2 was unrelated to both study product and injection procedure.
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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 | Group 1: No Treatment Control Group | Participants in this group received no treatment at baseline of the study. The events were unrelated to both study product and injection procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | Galderma Research & Development, LLC | 8179615000 | aestheticclinicaltrials@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 | Jun 29, 2022 | Mar 12, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2022 | Feb 27, 2026 | SAP_001.pdf |
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| Medical Reason |
|
| Death |
|
Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109.
| 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 |
|
| OG000 |
| Group 1: No Treatment Control Group |
Participants received no treatment at baseline. At Month 12, participants were offered to receive optional treatment with GP0109. |
| OG001 | Group 2: Treatment With GP0109 | Participants received GP0109 injection in the jawline at Day 1 and one optional touch-up treatment after 1 month of initial treatment. At Month 12, participants were offered to receive an additional optional treatment with GP0109. |
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Group 2: Initial Treatment With GP0109 | Participants who received initial treatment with GP0109 injection at Day 1 and one optional touch-up treatment at 1 month after the initial treatment were included. Participants randomized to no treatment at baseline and received initial GP0109 treatment at Month 12 were also included in this arm. | 1 | 214 | 9 | 214 | 12 | 214 |
| EG002 | Group 3: Re-treatment With GP0109 | Participants received re-treatment with GP0109 after Month 12 of the study. | 0 | 100 | 1 | 100 | 5 | 100 |
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| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Spondylitic myelopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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| Coronary artery disease | Cardiac disorders | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment | The event was unrelated to both study product and injection procedure. |
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