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This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Contour | Device | a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL) |
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| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50% | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by blinded evaluator at Month 3, compared with a reference standard responder rate of 50%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Phoenix | Arizona | 85054 | United States | ||
| Galderma Research Site |
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A total of 225 participants were randomized in a 4:1 ratio to either the Restylane Contour group or the no treatment group.
The study was conducted at 15 study centers in the United States from 14 March 2023 to 11 December 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Contour | Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 14, 2024 | Apr 28, 2026 |
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| Baseline, Month 3 |
| Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by a blinded evaluator at Months 6, 9 and 12 are reported here. | Months 6, 9 and 12 |
| Encino |
| California |
| 91436 |
| United States |
| Galderma Research Site | Los Angeles | California | 90069 | United States |
| Galderma Research Site | Redondo Beach | California | 90277 | United States |
| Galderma Research Site | Solana Beach | California | 92075 | United States |
| Galderma Research Site | Vista | California | 92083 | United States |
| Galderma Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| Galderma Research Site | Adventura | Florida | 33180 | United States |
| Galderma Research Site | Boynton Beach | Florida | 33437 | United States |
| Galderma Research Site | Coral Gables | Florida | 33146 | United States |
| Galderma Research Site | New Orleans | Louisiana | 70115 | United States |
| Galderma Research Site | New York | New York | 10021 | United States |
| Galderma Research Site | Chapel Hill | North Carolina | 27517 | United States |
| Galderma Research Site | Wilmington | North Carolina | 28405 | United States |
| Galderma Research Site | Nashville | Tennessee | 37203 | United States |
| FG001 |
| No-treatment Control Group |
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline. |
| Safety Population | The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle. |
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| COMPLETED |
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| NOT COMPLETED |
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The Intention-to-Treat (ITT) population included all participants who were randomized and were analyzed according to the randomization scheme.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Contour | Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator. |
| BG001 | No-treatment Control Group | Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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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| 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 | Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method. | Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Baseline, Month 3 |
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| Secondary | Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50% | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by blinded evaluator at Month 3, compared with a reference standard responder rate of 50%. | Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, 'overall number of participants analyzed' = number of participants with available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the Restylane Contour group only. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Baseline, Month 3 |
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| Secondary | Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator | Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by a blinded evaluator at Months 6, 9 and 12 are reported here. | Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, 'number analyzed' = number of participants with available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the Restylane Contour group only. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Months 6, 9 and 12 |
|
From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
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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 Contour | Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator. | 0 | 181 | 7 | 181 | 61 | 181 |
| EG001 | No-treatment Control Group | Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline. | 0 | 43 | 1 | 43 | 10 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Actinic cheilitis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Triple negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Non-systematic Assessment |
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| Dry eye | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Amblyopia | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA version 25.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 25.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 25.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Clinical Project Manager | Galderma | +1 817-961-5000 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2024 | Apr 28, 2026 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
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| Units | Counts |
|---|---|
| Participants |
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