Clinical trial NCT05982535: Neopep-S Ingredient Easy Dew MD Regen Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Transepidermal water loss
timeFrame: before and one month after medical device application
Secondary outcomes:
measure: Investigator Global Assessment Scale
timeFrame: before medical device application and one month after medical device application
measure: Dermatology Life Quality Index
timeFrame: before medical device application and one month after medical device application
measure: Itching score
timeFrame: before medical device application and one month after medical device application
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: CGBio Inc.
name: Jihye Lee
role: STUDY_DIRECTOR
References: