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Completed

NCT Number: NCT05982535

Neopep-S Ingredient Easy Dew MD Regen Cream

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.

Completed

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Key information

Conditions

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Gyeonggi-do, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Easy Dew MD Regen Cream

Device

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

Primary outcomes

  1. Transepidermal water loss

    Time frame: before and one month after medical device application

    Percutaneous moisture loss measured

Secondary outcomes

  1. Investigator Global Assessment Scale

    Time frame: before medical device application and one month after medical device 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 medical device application and one month after medical device application

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

  3. Itching score

    Time frame: before medical device application and one month after medical device application

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

Sponsors and collaborators

Lead sponsor

Eun-ji Kim

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 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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