DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Rash Acneiform

Intervention / Treatment
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* Biological: DWP708


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: older than 19 Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0) Patients who are currently administering EGFR TKI or EGFR mAb Exclusion Criteria: Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial Patients with a history of topical medication Steroids within 3 days prior to baseline visit Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo of DWP708<br>EGF Cream Placebo evenly apply to skin lesion every 12 hr/day | Biological: DWP708<br>* 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<br>* Other names: EGF cream;|
| Experimental: DWP708 10 ug/g<br>EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day | Biological: DWP708<br>* 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<br>* Other names: EGF cream;|
| Experimental: DWP708 20 ug/g<br>EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day | Biological: DWP708<br>* 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<br>* Other names: EGF cream;|
| Experimental: DWP708 40 ug/g<br>EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day | Biological: DWP708<br>* 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<br>* Other names: EGF cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the response rate of Rash acneiform | The effectiveness of the DWP708 was defined as follows: Downgraded to more than 2 steps Downgraded to ≤Grade 1 | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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) | Up to 56 days |