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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS23762 | Other Identifier | EU PAS |
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Study discontinued due to business decisions.
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The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BELKYRA Inj. | Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BELKYRA Inj. | Drug | Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | A validated scale used by investigators to assess SM convexity/amount of SMF. Specifically, the CR-SMFRS ranges in whole number increments from 0 (absent submental convexity) to 4 (extreme submental convexity) | Baseline, Follow up visit (within 3 months of injection) |
| Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Validated scale used by patients to evaluate SM size. Specifically, the PR-SMFRS asks patients to assess how much fat they have under their chins by selecting options ranging from "no chin fat at all" to "a very large amount of chin fat". | Baseline, Follow up visit (within 3 months of injection) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include adult patient is an adult (≥ 18 years of age) in South Korea treated with BELKYRA for the improvement of moderate to severe convexity or fullness associated with submental fat in adults
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne St. Rose, DVM, MSc, PhD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oracle-Dermatology | Daejeon | 35234 | South Korea | |||
| Goldenview plastic surgery |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance." | View source |
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| Seoul |
| 06010 |
| South Korea |
| (Apgujeong) Oracle-Dermatology | Seoul | 06022 | South Korea |
| Dream-Dermatology | Seoul | 06030 | South Korea |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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