Neopep-S Ingredient Easy Dew MD Regen Cream

Dry Skin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982535
• Other study ID #: G2206
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: August 2023
• Source: CGBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Skin

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Eun-ji Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss	Percutaneous moisture loss measured	before and one month after medical device application
Secondary	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
Secondary	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
Secondary	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