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CompletedNCT05378360Updated Apr 4, 2024

DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

A Phase 2 interventional study of DWP708 in Rash Acneiform, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Rash Acneiform
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Placebo comparator
    Placebo of DWP708

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

    Biological: DWP708

  • Experimental
    DWP708 10 ug/g

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

    Biological: DWP708

  • Experimental
    DWP708 20 ug/g

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

    Biological: DWP708

  • Experimental
    DWP708 40 ug/g

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

    Biological: DWP708

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

    Also known as: EGF cream

06

What researchers measure

Primary outcomes

  1. To estimate the response rate of Rash acneiform

    The effectiveness of the DWP708 was defined as follows: 1. Downgraded to more than 2 steps 2. Downgraded to ≤Grade 1

    Time frame: Up to 28 days

Secondary outcomes

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

    SKINDEX-16

    Time frame: Up to 56 days

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

    Region of interest (10 \* 10 cm)

    Time frame: Up to 56 days

07

Study locations

1 site
  • Dong-A University Hospital
    Busan, 49201, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05378360
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
May 18, 2022
Start date
May 2, 2022
Primary completion
Dec 5, 2023
Completion
Dec 28, 2023
Last update
Apr 4, 2024

Study contacts

Sung Yong Oh, M.D.
principal investigator · Dong-A University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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