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The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.
Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEA-033 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| description of AE profile | ||
| changes in laboratory values | ||
| IDEA-033 plasma levels | ||
| visual assessment of skin at target area(s) | ||
| physical exam | ||
| vital signs |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of efficacy by real time feedback |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilka Rother | X-pert-med GmbH Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| X-pert med GmbH / Ilka Rother | Gräfelfing | Bavaria | 82166 | Germany |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |