Rash AcneiformPhase 2NCT05378360
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
A Phase 2 study testing DWP708 in people with Rash Acneiform, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rash Acneiform
- What is being tested?
- DWP708
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2022to 28 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Rash Acneiform
- Being tested
- DWP708
- Medical subject headings
- Acneiform Eruptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP708Biological
Also called EGF cream
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo of DWP708 | Placebo comparator | EGF Cream Placebo evenly apply to skin lesion every 12 hr/day Receives: Biological: DWP708 |
| DWP708 10 ug/g | Experimental | EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day Receives: Biological: DWP708 |
| DWP708 20 ug/g | Experimental | EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day Receives: Biological: DWP708 |
| DWP708 40 ug/g | Experimental | EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day Receives: Biological: DWP708 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 28 days
Secondary outcomes (2)
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
SKINDEX-16
Measured: Up to 56 days
To estimate the amount of change papule and/or pustule
Region of interest (10 * 10 cm)
Measured: Up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start2 May 2022
- Primary completion5 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rash AcneiformStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Yong Oh, M.D., Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378360
- Sponsor's protocol ID
- DW_DWP708201
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05378360
- Acronym / sponsor ID
- DW_DWP708201
- Conditions
- Rash Acneiform
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo of DWP708 | Placebo comparator | Biological: DWP708EGF Cream Placebo evenly apply to skin lesion every 12 hr/day |
| DWP708 10 ug/g | Experimental | Biological: DWP708EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day |
| DWP708 20 ug/g | Experimental | Biological: DWP708EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day |
| DWP708 40 ug/g | Experimental | Biological: DWP708EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
- Patients with a history of topical medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWP708Also: EGF creamPlacebo 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 | Biological | DWP708 10 ug/g, DWP708 20 ug/g, DWP708 40 ug/g, Placebo of DWP708 |
Primary outcome
To estimate the response rate of Rash acneiform
Time frame: Up to 28 days
The effectiveness of the DWP708 was defined as follows: 1. Downgraded to more than 2 steps 2. Downgraded to ≤Grade 1
2 secondary outcomes
To evaluate the patients' Quality of Life (QoL) by Skin evaluation method
Time frame: Up to 56 days
To estimate the amount of change papule and/or pustule
Time frame: Up to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Oh, M.D. principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWP708 in people with Rash Acneiform, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the response rate of Rash acneiform (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.