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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
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
Dong-A University Hospital
Busan, South Korea
To estimate the response rate of Rash acneiform
The effectiveness of the DWP708 was defined as follows: 1. Downgraded to more than 2 steps 2. Downgraded to ≤Grade 1
Time frame: Up to 28 days
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
SKINDEX-16
Time frame: Up to 56 days
To estimate the amount of change papule and/or pustule
Region of interest (10 \* 10 cm)
Time frame: Up to 56 days
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