Skin LesionNCT05994781
A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream
A study testing EasyDew MD regen cram 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 olderHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion
- What is being tested?
- EasyDew MD regen cram
- 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 30 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults over the age of 19
- Subjects with partial layer skin transplantation
- There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise
- Decide to participate in this clinical study arbitrarily and in the written informed consent a person
Who cannot join
- showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case
- 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: A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation
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
Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. 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.
In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.
The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.
- Conditions
- Skin Lesion
- Being tested
- EasyDew MD regen cram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyDew MD regen cramDevice
Also called No treatment
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available. |
| Treatment | 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: EasyDew MD regen cram |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL score
Transepidermal water loss score/ No range of upper and lower score, the lower is best
Measured: Before, after one month after application, 3 month after application
Secondary outcomes (4)
Investigator Global Assessment scale
Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
Measured: Before, after one month after application, 3 month after application
Dermatology Life Quality Index
Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
Measured: Before, after one month after application, 3 month after application
itching scale
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start11 Nov 2022
- Primary completion27 Jun 2023
- Study completion30 Jun 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
- NCT05994781
- Sponsor's protocol ID
- G2205
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 22 Aug 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation
- ClinicalTrials.gov ID
- NCT05994781
- Acronym / sponsor ID
- G2205
- 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 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Aug 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
Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. 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.
In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.
The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will 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 |
|---|---|---|
| No treatment | No intervention | –The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available. |
| Treatment | Experimental | Device: EasyDew MD regen cramIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults over the age of 19
- Subjects with partial layer skin transplantation
- There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise
- Decide to participate in this clinical study arbitrarily and in the written informed consent a person
Key exclusion criteria (3 listed)
- showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case
- 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 |
|---|---|---|
| EasyDew MD regen cramAlso: No treatmentNo intervention | Device | Treatment |
Primary outcome
TEWL score
Time frame: Before, after one month after application, 3 month after application
Transepidermal water loss score/ No range of upper and lower score, the lower is best
4 secondary outcomes
Investigator Global Assessment scale
Time frame: Before, after one month after application, 3 month after application
Dermatology Life Quality Index
Time frame: Before, after one month after application, 3 month after application
itching scale
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
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 22 Aug 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 EasyDew MD regen cram 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 4 inclusion and 3 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 22 Aug 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?
TEWL score (time frame: Before, after one month after application, 3 month after application). 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 22 Aug 2023.