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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05378360

Enrollment

Registered

2022-05-18

Start date

2022-05-02

Completion date

2023-12-28

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rash Acneiform

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

Interventions

BIOLOGICALDWP708

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026