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| Name | Class |
|---|---|
| Merz North America, 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 Xeomin 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 Xeomin 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 0.05 mL and the OLD concentration is defined as 4 Units per 0.1 mL.
The total Xeomin 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 0.05 mL) group will receive a total of 0.25mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLD (4 U per 0.1 mL) | Active Comparator | Participants will receive a total Xeomin dose of 20U using a 4U per 0.1mL concentration divided into 5 intramuscular injections performed once. |
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| COLD (4 U per 0.05 mL group) | Active Comparator | Participants will receive a total Xeomin dose of 20U using a 4U per 0.05mL concentration divided into 5 intramuscular injections performed once. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | Injection of glabellar rhytids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Duration | Time to return to baseline Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Live Assessment (Dynamic) | Responder rate at each visit on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Hayes | Contact | 747-998-5160 | mary@clinicaltestingcenter.com | |
| John Joseph, MD | Contact | 8186163880 | drjohnjoseph@sbcglobal.net |
| 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 | ||
| Alexander Rivkin MD |
| 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. | |
| 23650444 | Background | Prager W, Bee EK, Havermann I, Zschocke I. Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study. Clin Interv Aging. 2013;8:449-56. doi: 10.2147/CIA.S34854. Epub 2013 Apr 24. |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| Subject Self Assessment (Dynamic) |
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the subject. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. |
| 180 days |
| Investigator Live Assessment (At Rest) | Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 180 days |
| Subject Self Assessment (At Rest) | Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the subject. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 180 days |
| Change from Baseline Score | Change from baseline in mean Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator, at each visit. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles. | 180 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. | 180 days |
| Los Angeles |
| California |
| 90025 |
| United States |
|