Neopep-S Ingredient Easy Dew MD Regen Cream

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.

Study Overview

• Status: Completed
• Conditions: Dry Skin
• Intervention / Treatment: Device: Easy Dew MD Regen Cream

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects diagnosed with xerotic skin among adults aged 19 to 80 years
2. Subjects who have voluntarily decided to participate in this clinical study and signed a written informed consent

Exclusion Criteria:

1. Subjects with uncontrolled diabetes
2. 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
3. Acute or chronic skin disease; stage in progress or active in the area of application Subject to bacterial or viral infection
4. Where the researcher's judgment determines that participation in the study is inappropriate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Easy Dew MD Regen Cream; 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.	Device: Easy Dew MD Regen Cream; 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.; Other Names: Physiogel Stability Intensive Cream MD
Active Comparator: 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.	Device: Easy Dew MD Regen Cream; 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.; Other Names: Physiogel Stability Intensive Cream MD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss	Percutaneous moisture loss measured	before and one month after medical device application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment Scale	Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)	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)	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)	before medical device application and one month after medical device application

Collaborators and Investigators

• Sponsor: Eun-ji Kim
• Investigators: Study Director: Jihye Lee, CGBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: G2206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No