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OpenTrials
Completed

NCT Number: NCT05378360

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 for Treating Rash Acneiform

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Key information

Conditions

Rash Acneiform Acneiform Eruptions Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dong-A University Hospital

Busan, 49201, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWP708

Biological

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

Primary outcomes

  1. To estimate the response rate of Rash acneiform

    Time frame: Up to 28 days

    The effectiveness of the DWP708 was defined as follows:

    • Downgraded to more than 2 steps
    • Downgraded to ≤Grade 1

Secondary outcomes

  1. To evaluate the patients' Quality of Life (QoL) by Skin evaluation method

    Time frame: Up to 56 days

    SKINDEX-16

  2. To estimate the amount of change papule and/or pustule

    Time frame: Up to 56 days

    Region of interest (10 * 10 cm)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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