DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
NCT ID: NCT05378360
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2022-05-02
2023-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo of DWP708
EGF Cream Placebo evenly apply to skin lesion every 12 hr/day
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
DWP708 10 ug/g
EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day
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
DWP708 20 ug/g
EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day
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
DWP708 40 ug/g
EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Sung Yong Oh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Locations
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Dong-A University Hospital
Busan, , South Korea
Countries
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Other Identifiers
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DW_DWP708201
Identifier Type: -
Identifier Source: org_study_id
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