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A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform
All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo of DWP708 | Placebo Comparator | EGF Cream Placebo evenly apply to skin lesion every 12 hr/day |
|
| DWP708 10 ug/g | Experimental | EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day |
|
| DWP708 20 ug/g | Experimental | EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day |
|
| DWP708 40 ug/g | Experimental | EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP708 | Biological | Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the response rate of Rash acneiform | The effectiveness of the DWP708 was defined as follows:
| Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the patients' Quality of Life (QoL) by Skin evaluation method | SKINDEX-16 | Up to 56 days |
| To estimate the amount of change papule and/or pustule | Region of interest (10 * 10 cm) |
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Inclusion Criteria:
Exclusion Criteria:
Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
Patients with a history of topical medication
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| Name | Affiliation | Role |
|---|---|---|
| Sung Yong Oh, M.D. | Dong-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | 49201 | South Korea |
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| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Up to 56 days |