DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

Phase 2

Completed

• Conditions: Rash Acneiform

• Registration Number: NCT05378360
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-02
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-28
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Age: older than 19
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
3. Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
4. Patients who are currently administering EGFR TKI or EGFR mAb

Exclusion Criteria

1. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial

2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To estimate the response rate of Rash acneiform	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 Outcome Measures

Name	Time	Method
To estimate the amount of change papule and/or pustule	Up to 56 days	Region of interest (10 \* 10 cm)
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method	Up to 56 days	SKINDEX-16

Trial Locations

Locations (1)

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of