A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708

Daewoong Pharmaceutical Co. LTD.1 site in 1 country96 target enrollmentMay 2, 2022

ConditionsRash Acneiform

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rash Acneiform
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 96
Locations: 1
Primary Endpoint: To estimate the response rate of Rash acneiform
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

May 2, 2022

End Date

December 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

To estimate the response rate of Rash acneiform

Time Frame: Up to 28 days

The effectiveness of the DWP708 was defined as follows: 1. Downgraded to more than 2 steps 2. Downgraded to ≤Grade 1

Secondary Outcomes

To estimate the amount of change papule and/or pustule(Up to 56 days)
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method(Up to 56 days)