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Principal aim of this study is to assess whether a combination of topical dapsone and clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily exploratory and essentially meant to inform the sponsor whether further development of a combination treatment formulation is warranted
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dapsone gel - verum | Active Comparator | dapsone gel - verum |
|
| dapsone gel - vehicle only | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapsone gel - verum | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus based on visual analogue scale in side to side comparison | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 5 D itch scale in side to side comparison | 8 weeks |
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Inclusion Criteria:
• Active prurigo nodularis or lichen simplex chronicus - diagnosed by clinical exam
Exclusion Criteria:
• History of non-compliance with follow up visits
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joerg Albrecht, MD | Contact | 3128644480 | jalbrecht@cookcountyhhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Joerg Albrecht, MD | J.H.Stroger Hospital of Cook County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| J H Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2023 | |
| Reset | Jul 3, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2023 | Jul 3, 2023 |
| ID | Term |
|---|---|
| D011536 | Prurigo |
| D009450 | Neurodermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
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