Back to resultsDWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
Primary Purpose
Rash Acneiform
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWP708
Sponsored by
About this trial
This is an interventional treatment trial for Rash Acneiform
Eligibility Criteria
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
Sites / Locations
- Dong-A University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo of DWP708
DWP708 10 ug/g
DWP708 20 ug/g
DWP708 40 ug/g
Arm Description
EGF Cream Placebo evenly apply to skin lesion every 12 hr/day
EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day
EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day
EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day
Outcomes
Primary Outcome Measures
To estimate the response rate of Rash acneiform
The effectiveness of the DWP708 was defined as follows:
Downgraded to more than 2 steps
Downgraded to ≤Grade 1
Secondary Outcome Measures
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
SKINDEX-16
To estimate the amount of change papule and/or pustule
Region of interest (10 * 10 cm)
Full Information
NCT ID
NCT05378360
First Posted
May 12, 2022
Last Updated
May 22, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05378360
Brief Title
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rash Acneiform
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo of DWP708
Arm Type
Placebo Comparator
Arm Description
EGF Cream Placebo evenly apply to skin lesion every 12 hr/day
Arm Title
DWP708 10 ug/g
Arm Type
Experimental
Arm Description
EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day
Arm Title
DWP708 20 ug/g
Arm Type
Experimental
Arm Description
EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day
Arm Title
DWP708 40 ug/g
Arm Type
Experimental
Arm Description
EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day
Intervention Type
Biological
Intervention Name(s)
DWP708
Other Intervention Name(s)
EGF cream
Intervention Description
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
Primary Outcome Measure Information:
Title
To estimate the response rate of Rash acneiform
Description
The effectiveness of the DWP708 was defined as follows:
Downgraded to more than 2 steps
Downgraded to ≤Grade 1
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
Description
SKINDEX-16
Time Frame
Up to 56 days
Title
To estimate the amount of change papule and/or pustule
Description
Region of interest (10 * 10 cm)
Time Frame
Up to 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Yeon Park
Phone
+82-2-550-8800
Email
jypark188@daewoong.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Yong Oh, M.D.
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Yong Oh, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
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