A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream

NCT05994781 | Completed

• 1 other identifier: G2205
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• TEWL score

  Transepidermal water loss score/ No range of upper and lower score, the lower is best

  Before, after one month after application, 3 month after application

Secondary Outcomes (4)

• Investigator Global Assessment scale

  Before, after one month after application, 3 month after application

• Dermatology Life Quality Index

  Before, after one month after application, 3 month after application

• itching scale

  Before, after one month after application, 3 month after application

• VSS

  Before, after one month after application, 3 month after application

Study Arms (2)

No treatment

NO INTERVENTION

The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available.

Treatment

EXPERIMENTAL

In the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.

Device: EasyDew MD regen cram

Interventions

EasyDew MD regen cram DEVICE

No intervention

Also known as: No treatment

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults over the age of 19
• Subjects with partial layer skin transplantation
• There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise
• Decide to participate in this clinical study arbitrarily and in the written informed consent a person

You may not qualify if:

• showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case
• In situations where the requirements of a clinical study cannot be complied with
• When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)

Sponsors & Collaborators

• Eun-ji Kim: lead

Study Sites (1)

Ajou University Hospital

Gyeonggi-do, South Korea

Location

Study Officials

• Jihye Lee, Master

  CGBio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial Manager

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: November 11, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 30, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)