Laser-Induced ScarNCT05982509
Clinical Trial to Assess the Efficacy and Safety of EASYDEW MD REGEN Cream Containing Neopop-S.
A study testing EasyDew Regen MD Cream in people with Laser-Induced Scar, run by Eun-ji Kim at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser-Induced Scar
- What is being tested?
- EasyDew Regen MD Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2022to 27 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues
- Decided to participate in this clinical study and signed a written informed consent the subject
Who cannot join
- Subjects with uncontrolled diabetes
- Subjects with uncontrolled hypertension and cardiovascular disease
- Subjects with hemorrhagic diseases such as hemophilia
- Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results Subjects who are or are scheduled to receive medication for an extended period of time
- Acute or chronic skin disease causes stage progression or active bacteria in the application area Who has a virus infection
- When the researcher's judgment determines that participation in the study is inappropriate (e.g. keloid constitution)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess the Efficacy and Safety of Neopop-S Containing EASYDEW
The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.
Read the detailed description
This clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research.
The subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study.
The screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research.
Participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio.
- Control group: 10 people without treatment
- Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are randomly assigned to control and study groups. In the case of the study group, the Easy Dew Regen MD cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. The control group is the non-chalant group. However, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well.
One month of clinical research medical device application will be observed, and subjects will regularly visit the research institution to evaluate its validity and safety during screening visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after treatment (Visit3) You will receive it.
- Conditions
- Laser-Induced Scar
- Being tested
- EasyDew Regen MD Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyDew Regen MD CreamDevice
For the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Control group: 10 people without treatment |
| Treatment | Experimental | Study Group: 10 People Applying EasyDew Regen MD Cream Receives: Device: EasyDew Regen MD Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss Transcutaneous water loss (TEWL) measured
Before, immediately after treatment, and one month after application of the medical device Transcutaneous water loss (TEWL) measured
Measured: Before, immediately after treatment, and one 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 posted8 Aug 2023
- Study start11 Nov 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laser-Induced ScarStudies 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
- 20 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, Study director, CGBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982509
- Sponsor's protocol ID
- G2204
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YH, Lee SJ, Kim HS, Son SW, Kim MJ, Lim H, Lee IJ, Park YJ. Attenuation of Subclinical TNF-alpha Signalling in Xerotic Skin by AIMP-1 Derived Peptide Containing Moisturiser Leads to Skin Barrier Recovery. Exp Dermatol. 2025 Dec;34(12):e70183. doi: 10.1111/exd.70183.
PubMed 41355341
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Efficacy and Safety of Neopop-S Containing EASYDEW
- ClinicalTrials.gov ID
- NCT05982509
- Acronym / sponsor ID
- G2204
- Conditions
- Laser-Induced Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eun-ji KimIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 8 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.
The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.
Detailed description
This clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research.
The subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study.
The screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research.
Participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio.
- Control group: 10 people without treatment
- Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are randomly assigned to control and study groups. In the case of the study group, the Easy Dew Regen MD cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. The control group is the non-chalant group. However, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well.
One month of clinical research medical device application will be observed, and subjects will regularly visit the research institution to evaluate its validity and safety during screening visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after treatment (Visit3) You will receive it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Control group: 10 people without treatment |
| Treatment | Experimental | Device: EasyDew Regen MD CreamStudy Group: 10 People Applying EasyDew Regen MD Cream |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues
- Decided to participate in this clinical study and signed a written informed consent the subject
Key exclusion criteria (6 listed)
- Subjects with uncontrolled diabetes
- Subjects with uncontrolled hypertension and cardiovascular disease
- Subjects with hemorrhagic diseases such as hemophilia
- Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results Subjects who are or are scheduled to receive medication for an extended period of time
- Acute or chronic skin disease causes stage progression or active bacteria in the application area Who has a virus infection
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 Regen MD CreamFor the study group, I received the prescription Easy Dew Regen MD Cream from Picosure Laser Apply an appropriate amount twice a day (morning and evening) to the skin of the area so that it can be absorbed well do. The control group is the non-chalant group. However, for one month after the procedure, it is not a medical device The normal moisturizer you use at home is available, and the area where you have undergone laser treatment Apply it twice a day (morning and evening) to the skin so that it can be absorbed well. | Device | Treatment |
Primary outcome
Transepidermal water loss Transcutaneous water loss (TEWL) measured
Time frame: Before, immediately after treatment, and one month after application
Before, immediately after treatment, and one month after application of the medical device Transcutaneous water loss (TEWL) measured
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 8 Aug 2023.
- Derived from this study: PubMed 41355341Kim YH, Lee SJ, Kim HS, Son SW, Kim MJ, Lim H, Lee IJ, Park YJ. Attenuation of Subclinical TNF-alpha Signalling in Xerotic Skin by AIMP-1 Derived Peptide Containing Moisturiser Leads to Skin Barrier Recovery. Exp Dermatol. 2025 Dec;34(12):e70183. doi: 10.1111/exd.70183.
- 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 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 Regen MD Cream in people with Laser-Induced Scar, 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 2 inclusion and 6 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 8 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?
Transepidermal water loss Transcutaneous water loss (TEWL) measured (time frame: Before, immediately after treatment, and one month after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982509, which also lists 1 linked publication.
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 8 Aug 2023.