A human study to evaluate the skin health improvement effect and safety of ME-100

Not Applicable

Recruiting

• Conditions: Diseases of the skin and subcutaneous tissue

• Registration Number: KCT0004820
• Lead Sponsor: Kyung Hee University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1)Subject who voluntarily agree to participate and signs informed consent form
2)Men and women aged 30 to under 60
3)Subject who has a dry skin (skin moisture content index below 49AU measured using Corneometer®), eye wrinkles begin to form or have already formed (visual evaluation grade 3 or higher).

Exclusion Criteria

1)Subjects with abnormal skin conditions such as spots, acne, erythema, and capillary dilation in the test area
2)Subjects who have or are currently undergoing treatment for skin diseases such as atopic dermatitis and psoriasis
3)Subjects who take contraceptives or hormones or diuretics
4)Subjects who take a oral retinoid/steroid agent or use a skin external substance containing steroids or retinoids within 3 months before the first visit
5)Subjects who use a functional cosmetic (retinoid agent, retinol, AHA) to improve wrinkles or moisturizing cosmetic within 2 weeks before the first visit
6)Subjects who received treatment(skin stripping, lazer, chemical peeling, other skin care, etc.) on the facial area within 1 month or received treatment(botox, filler) on the facial area within 6 months before the first visit
7)Subjects with diseases such as uncontrolled hypertension, uncontrolled diabetes, renal dysfunction, liver dysfunction, etc.
8)Subjects who have been continuously consumed any healthy functional food within 1 month before the first visit
9)Smokers or Subjects who smoke less than a year after quitting smoking
10)Participation in other human study within 1 month before the first visit
11)Subjects who are pregnant, nursing, or planning to conceive
12)Subjects with hypersensitivity to test materials
13)Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin moisture content, Transepidermal water loss, Keratin mass, Skin elasticity, Skin texture, Eye wrinkle;General improvement self evaluation

Secondary Outcome Measures

Name	Time	Method
Clinical laboratory test(blood, urine);Adverse events