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The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradermal injection | Experimental | Restylane and/or Perlane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane | Device | Facial tissue augmentation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant | Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds". A participant is considered improved if she scores at least one grade improvement from baseline. |
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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 | Kaohsiung City | Taiwan | ||||
| Galderma Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intradermal Injection | Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment |
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| Second Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intradermal Injection | Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation |
| 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 Improved in "Global Facial Aesthetic Appearance" - Judged by Participant | Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 Months |
|
|
2 years, 4 months
Each subject was to be questioned about AEs at each study visit following the Screening Visit.
The question to be asked was:"Since your last clinical visit have you had any health problems?" Information on AEs could also be obtained from signs and symptoms detected during an examination or from a laboratory test, observations made by the study site personnel, subject diaries, or spontaneous reports from subjects or their relatives.
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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 | Intradermal Injection | Restylane and/or Perlane Restylane: Facial tissue augmentation Perlane: Facial tissue augmentation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic paranasal sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Perlane |
| Device |
Facial tissue augmentation |
|
| 6 and 12 Months after first and second treatment, respectively |
| Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek". A participant is assessed as improved if she scores at least one grade improvement from baseline. | 6 and 12 Months after first and second treatment, respectively |
| Taipei |
| Taiwan |
| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds". A participant is considered improved if she scores at least one grade improvement from baseline. | In total, 88 participants were injected in the right NLF and 86 participants were injected in the left NLF | Posted | Number | 95% Confidence Interval | percentage of participants | 6 and 12 Months after first and second treatment, respectively |
|
|
|
| Secondary | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek". A participant is assessed as improved if she scores at least one grade improvement from baseline. | All 100 participants were injected in the upper cheeks, but 1 participant was not injected in left upper cheek at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 and 12 Months after first and second treatment, respectively |
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| 0 |
| 100 |
| 5 |
| 100 |
| 34 |
| 100 |
| Herpes simplex progenitalis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Intraductal papilloma (benign) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Left ovary tumor with endometrial polyps | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Implant site bruising | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
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| 12 Months after first treatment |
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| 6 Months after second treatment |
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| 12 Months after second treatment |
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| 12 Months after first treatment |
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| 6 Months after second treatment |
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| 12 Months after second treatment |
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