Dry SkinNCT05982535
Neopep-S Ingredient Easy Dew MD Regen Cream
A study testing Easy Dew MD Regen Cream in people with Dry Skin, run by Eun-ji Kim at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to provide patients diagnosed with dry skin due to various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is intended to assess safety. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- 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
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with xerotic skin among adults aged 19 to 80 years
- Subjects who have voluntarily decided to participate in this clinical study and signed a written informed consent
Who cannot join
- Subjects with uncontrolled diabetes
- Immunosuppressants, corticosteroids, cytotoxic drugs, anticoagulants, etc. are included in the results You are on long-term or scheduled to receive medication that may affect you a person who is subject to
- Acute or chronic skin disease; stage in progress or active in the area of application Subject to bacterial or viral infection
- Where the researcher's judgment determines that participation in the study is inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Neopep-S Ingredient Easy Dew MD Regen Cream in the Indication of Dry Skin A Prospective Researcher-led Clinical Study to Assess Efficacy and Safety
The purpose of this clinical study is to provide patients diagnosed with dry skin due to various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is intended to assess safety.
Read the detailed description
The total study period for this clinical study is 12 months from the date of IRB approval, led by researchers from a single institution It's a clinical study. The individual participation period of the participant is one month.
Subjects are those diagnosed with dry skin due to a variety of factors (and/or courts) Agents) perform screening tests after agreeing in writing to participate in the clinical study.
Evaluating the screening test results, and subjects who meet the selection criteria and do not meet the exclusion criteria, for clinical research It must be registered. Random assignments of the study group and control group are conducted in a random number table at a 5:5 ratio.
- Control group: 10 people with dexian med cream
- Research Group: 10 people applying EasyDew MD Regen Cream Clinical study subjects are randomly assigned to control and study groups. The control group is Dexian, a foreign medical device product Med cream is applied, and in the case of the study group, EasyDewMD Regen cream provided through prescription is applied. clinical practice Subjects apply an appropriate amount twice a day (morning and evening) to skin areas with dry skin symptoms and can be absorbed well Let's make it happen. After applying the medical device for clinical research, the progress is observed for one month, and the subject is subject to about one month of clinical research During the period, research institutes will be regularly visited to evaluate their validity and safety on the day of screening (Visit1), the day of medical device application (Visit2), 2 weeks after medical device application (Visit3), and 1 month after application (Visit4).
- Conditions
- Dry Skin
- 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 | 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 |
| 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 after medical device application
Secondary outcomes (3)
Investigator Global Assessment Scale
Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
Measured: before medical device application and one month after medical device application
Dermatology Life Quality Index
Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
Measured: before medical device application and one month after medical device application
Itching score
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
Measured: before medical device application and one month after medical device 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.
- Other trials for Dry SkinStudies 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
- NCT05982535
- Sponsor's protocol ID
- G2206
- 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
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
- The Application of Neopep-S Ingredient Easy Dew MD Regen Cream in the Indication of Dry Skin A Prospective Researcher-led Clinical Study to Assess Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05982535
- Acronym / sponsor ID
- G2206
- Conditions
- Dry Skin
- 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 provide patients diagnosed with dry skin due to various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is intended to assess safety.
Detailed description
The total study period for this clinical study is 12 months from the date of IRB approval, led by researchers from a single institution It's a clinical study. The individual participation period of the participant is one month.
Subjects are those diagnosed with dry skin due to a variety of factors (and/or courts) Agents) perform screening tests after agreeing in writing to participate in the clinical study.
Evaluating the screening test results, and subjects who meet the selection criteria and do not meet the exclusion criteria, for clinical research It must be registered. Random assignments of the study group and control group are conducted in a random number table at a 5:5 ratio.
- Control group: 10 people with dexian med cream
- Research Group: 10 people applying EasyDew MD Regen Cream Clinical study subjects are randomly assigned to control and study groups. The control group is Dexian, a foreign medical device product Med cream is applied, and in the case of the study group, EasyDewMD Regen cream provided through prescription is applied. clinical practice Subjects apply an appropriate amount twice a day (morning and evening) to skin areas with dry skin symptoms and can be absorbed well Let's make it happen. After applying the medical device for clinical research, the progress is observed for one month, and the subject is subject to about one month of clinical research During the period, research institutes will be regularly visited to evaluate their validity and safety on the day of screening (Visit1), the day of medical device application (Visit2), 2 weeks after medical device application (Visit3), and 1 month after application (Visit4).
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 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. |
| 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 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects diagnosed with xerotic skin among adults aged 19 to 80 years
- Subjects who have voluntarily decided to participate in this clinical study and signed a written informed consent
Key exclusion criteria (4 listed)
- Subjects with uncontrolled diabetes
- Immunosuppressants, corticosteroids, cytotoxic drugs, anticoagulants, etc. are included in the results You are on long-term or scheduled to receive medication that may affect you a person who is subject to
- Acute or chronic skin disease; stage in progress or active in the area of application Subject to bacterial or viral infection
- Where the researcher's judgment determines that participation in the study is inappropriate
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 after medical device application
Percutaneous moisture loss measured
3 secondary outcomes
Investigator Global Assessment Scale
Time frame: before medical device application and one month after medical device application
Dermatology Life Quality Index
Time frame: before medical device application and one month after medical device application
Itching score
Time frame: before medical device application and one month after medical device 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 8 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 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 Dry Skin, 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 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 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 (time frame: before and one month after medical device 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 8 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.