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| Name | Class |
|---|---|
| Evolus, Inc. | INDUSTRY |
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This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Jeuveau in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Jeuveau in subjects with moderate to severe dynamic glabellar lines at the approved on-label dose of 20 U, however comparing the use of highly Concentrated On Label Dose (COLD) to the On Label Dose and concentration (OLD). The COLD concentration is defined as 4 Units per 0.02 mL and the OLD concentration is defined as 4 Units per 0.1 mL.
The total Jeuveau dose will be 20U divided into 5 injections for both study groups. However, the injection volume will differ for the two study groups, such that the OLD (4 U per 0.1 mL) group will receive a total of 0.5 mL and the COLD (4 U per 0.02 mL) group will receive a total of 0.1mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLD (4 U per 0.1 mL) | Active Comparator | The total Jeuveau dose will be 20U divided into 5 injections. Each subject will receive a total of 0.5 mL of Jeuveau during the treatment. |
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| COLD (4 U per 0.02 mL group) | Active Comparator | The total Jeuveau dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL of Jeuveau during the treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prabotulinumtoxinA | Drug | Injection of glabellar rhytids |
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| Measure | Description | Time Frame |
|---|---|---|
| Response Duration | Time to return to baseline Glabellar Line Scale (GLS) score at maximum frown, as assessed by the blinded evaluating investigator. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 270 days |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Live Assessment (Dynamic) | Responder rate at each visit on the Glabellar Line Scale (GLS) at maximum frown, as assessed by the blinded evaluating investigator. The responder rate is defined as the proportion of subjects maintaining a greater than or equal to 1 point improvement on the FWS. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Joseph, MD | Clinical Testing of Beverly Hills | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Testing of Beverly Hills | Encino | California | 91436 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15507786 | Background | Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3. |
| Label | URL |
|---|---|
| Jeuveau Highlights of Prescribing Information. | View source |
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| ID | Term |
|---|---|
| C000630868 | prabotulinumtoxin A |
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| 270 days |
| Subject Self Assessment (Dynamic) | Responder rate at each visit on the Glabellar Line Scale (GLS) at maximum frown, as assessed by the subject. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 270 days |
| Investigator Live Assessment (At Rest) | Responder rate at each visit on the Glabellar Line Scale (GLS) at rest, as assessed by the blinded evaluating investigator. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 270 days |
| Subject Self Assessment (At Rest) | Responder rate at each visit on the Glabellar Line Scale (GLS) at rest, as assessed by the subject. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 270 days |
| Change from Baseline Score | Change from baseline in mean Glabellar Line Scale (GLS) score at maximum frown, as assessed by the blinded evaluating investigator, at each visit. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 270 days |
| Change in Frontalis Function | Percentage of subjects with weakening of frontalis muscle function using the Frontalis Function Scale (FFS) compared to baseline, as assessed by the blinded evaluating investigator, at each visit. The Frontalis Function Scale (FFS) scale ranges from a score of 0 to 3, and a higher score indicates greater reduction of forehead movement during maximal brow raise. | 270 days |