Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 12:39 PM
Study NCT ID:
NCT05982535
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neopep-S Ingredient Easy Dew MD Regen Cream
Sponsor:
Eun-ji Kim
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: