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Completed

NCT Number: NCT05994781

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

This clinical study is conducted prospectively for 3 months after medical device treatment.

It is a comparative clinical study of the leading control group.

Completed

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Gyeonggi-do, South Korea

About this study

Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study Perform a post-screening test.

Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria those who do not are registered for clinical research.

In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.

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. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.

Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

EasyDew MD regen cram

Device

No intervention

Other names: No treatment

Primary outcomes

  1. TEWL score

    Time frame: Before, after one month after application, 3 month after application

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

Secondary outcomes

  1. Investigator Global Assessment scale

    Time frame: Before, after one month after application, 3 month after application

    Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)

  2. Dermatology Life Quality Index

    Time frame: Before, after one month after application, 3 month after application

    Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)

  3. itching scale

    Time frame: Before, after one month after application, 3 month after application

    Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)

  4. VSS

    Time frame: Before, after one month after application, 3 month after application

    Vancouver Scar Scale/ No range of upper and lower score, the lower is best

Sponsors and collaborators

Lead sponsor

Eun-ji Kim

Industry

Registry information

Official study title

A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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