Skin LesionNCT06025058
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
A study testing Easy Dew MD Regen Cream in people with Skin Lesion, run by Eun-ji Kim at 1 site in South Korea.
Trial summary
This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Skin Lesion
- What is being tested?
- Easy Dew MD Regen Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2022to 28 Jul 2023
- Phase
- Interventional
- 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
- adults over the age of 19
- The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation
- Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom
Who cannot join
- When participating in a clinical study, the findings of radiation dermatitis in the area are shown
- A person who shows signs of acute or chronic dermatological diseases
- In situations where the requirements of a clinical study cannot be complied with
- When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Patients Under Radiotherapy After Breast Tumor Resection
This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.
Read the detailed description
Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion.
Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study.
Perform a post-screening test. Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria.
Those who do not are registered for clinical research.
- Control group: Physiogel Skin Stability Intensive Cream MD (10 people)
- Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are randomly assigned in a 2:1 ratio between the study group and the control group.
In this case, apply the control medical device twice a day (morning and evening) to the radiation treatment area.
Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the radiotherapy site.
Apply an appropriate amount twice a day (in the evening) to ensure good absorption.
The progress for three months after the application of medical devices for clinical research will be observed, and the subjects will be screening visit (Visit1), medical device application day (Visit2), medical device application, and medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and to be evaluated for safety.
- Conditions
- Skin Lesion
- Being tested
- Easy Dew MD Regen Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easy Dew MD Regen CreamDevice
Also called Physiogel Stability Intensive Cream MD
The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.
| Study group | Role | What they receive |
|---|---|---|
| Easy Dew MD Regen Cream | Experimental | In the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well. Receives: Device: Easy Dew MD Regen Cream |
| Physiogel Stability Intensive Cream MD | Active comparator | The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well. Receives: Device: Easy Dew MD Regen Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss
Percutaneous moisture loss measured
Measured: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Secondary outcomes (3)
Itching score
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst
Measured: Before, after one month after application, 3 month after application
VSS
Vancouver Scar Scale/ No range of upper and lower score, the lower is best
Measured: Before, after one month after application, 3 month after application
BREAST-Q Survey Assessment
Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)
Measured: Before, after one month after application, 3 month after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start11 Nov 2022
- Primary completion27 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eun-ji Kim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Eun-ji Kim, CGBio Inc.
- Investigators
- Jihye Lee, Master, Study director, CGBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025058
- Sponsor's protocol ID
- G2207
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 6 Sep 2023
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Patients Under Radiotherapy After Breast Tumor Resection
- ClinicalTrials.gov ID
- NCT06025058
- Acronym / sponsor ID
- G2207
- Conditions
- Skin Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eun-ji KimIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 6 Sep 2023 (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.
This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.
Detailed description
Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion.
Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study.
Perform a post-screening test. Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria.
Those who do not are registered for clinical research.
- Control group: Physiogel Skin Stability Intensive Cream MD (10 people)
- Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are randomly assigned in a 2:1 ratio between the study group and the control group.
In this case, apply the control medical device twice a day (morning and evening) to the radiation treatment area.
Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the radiotherapy site.
Apply an appropriate amount twice a day (in the evening) to ensure good absorption.
The progress for three months after the application of medical devices for clinical research will be observed, and the subjects will be screening visit (Visit1), medical device application day (Visit2), medical device application, and medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and to be evaluated for safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy Dew MD Regen Cream | Experimental | Device: Easy Dew MD Regen CreamIn the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well. |
| Physiogel Stability Intensive Cream MD | Active comparator | Device: Easy Dew MD Regen CreamThe subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults over the age of 19
- The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation
- Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom
Key exclusion criteria (4 listed)
- When participating in a clinical study, the findings of radiation dermatitis in the area are shown
- A person who shows signs of acute or chronic dermatological diseases
- In situations where the requirements of a clinical study cannot be complied with
- When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)
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 |
|---|---|---|
| Easy Dew MD Regen CreamAlso: Physiogel Stability Intensive Cream MDThe subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well. | Device | Easy Dew MD Regen Cream, Physiogel Stability Intensive Cream MD |
Primary outcome
Transepidermal water loss
Time frame: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Percutaneous moisture loss measured
3 secondary outcomes
Itching score
Time frame: Before, after one month after application, 3 month after application
VSS
Time frame: Before, after one month after application, 3 month after application
BREAST-Q Survey Assessment
Time frame: Before, after one month after application, 3 month after application
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 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jihye Lee, Master study director
CGBio Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Easy Dew MD Regen Cream in people with Skin Lesion, run by Eun-ji Kim 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 3 inclusion and 4 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 6 Sep 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Transepidermal water loss (time frame: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)). 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 6 Sep 2023.