DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

Daewoong Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Rash Acneiform

Treatments: Biological: DWP708

Study type: Interventional

Funder types: Industry

Identifiers

NCT05378360

DW_DWP708201

Details and patient eligibility

About

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

Full 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

Enrollment: 96 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 4 patient groups, including a placebo group

Placebo of DWP708

Placebo Comparator group

Description:

EGF Cream Placebo evenly apply to skin lesion every 12 hr/day

Treatment:

Biological: DWP708

DWP708 10 ug/g

Experimental group

Description:

EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day

Treatment:

Biological: DWP708

DWP708 20 ug/g

Experimental group

Description:

EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day

Treatment:

Biological: DWP708

DWP708 40 ug/g

Experimental group

Description:

EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day

Treatment:

Biological: DWP708