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Internal reasons
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An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial
As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMT101 | Experimental | BMT101 injection (treatment) |
|
| control | No Intervention | Un-treated control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMT101 | Drug | Intradermal injection to each of 3 dose-groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reducing the hypertrophic scar after scar revision surgery | to evaluate Differences in Visual Analogue Scale (VAS) score between the study group and the control group when independent evaluators assessed the severity of the hypertrophic scars. | Week 2, 6, 10, 22 |
| Safety evaluation of BMT101 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar | Week 2, 6, 10, 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugel | Seoul | South Korea |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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