DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

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

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

Study Overview

• Status: Completed
• Conditions: Rash Acneiform
• Intervention / Treatment: Biological: DWP708

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Sung Yong Oh, M.D., Dong-A University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions
• Other Study ID Numbers: DW_DWP708201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No