A comparative study of biological and metabolic biomarkers between healthy individuals and patients with acne vulgaris
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0002212
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Participation of the Population with Acne Vulgaris
Participants who will meet the following criteria will be included:
1) Age of 19 to 35 years
2) Body mass index (BMI) of 18.5 to 23 kg/m2
3) Acne vulgaris [20 individuals with Korean Acne Grading System (KAGS) Gr 1 or 2; 20 individuals with KAGS Gr 3 or 4; and 20 individuals with over KAGS Gr 5)
4) Voluntary participation in this clinical trial
Participation of the Healthy Controls
Participants who will meet the following criteria will be included:
1) Age of 19 to 35 years
2) BMI of 18.5 to 23 kg/m2
3) No evidence of acne
4) (Only for women) Regular menstrual cycle during the last 3 months
5) No digestive-related uncomfortable symptoms in usual situations
6) No abdominal muscle tension
7) Other disorders that may affect the outcomes
8) Voluntary participation in this clinical trial
Participants who will meet any of the following will be excluded:
1) Use of oral steroids, oral contraceptives, oral vitamin A derivatives, antibiotics, or herbal medicines that may affect the test results during the last 4 weeks
2) No fasting for more than 8 hours after 9:00 pm on the day before the visit
3) Alcohol drinking within the last week
4) Smoking
5) Pregnancy or lactation
6) Judgment that physical or mental testing is not appropriate for the clinical trial
7) Participation in other clinical trials that may affect this trial
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular biological biomarker [1) Inflammatory indexes: 6 Cytokines related with the Inflammation(IL-1a, IL-1b, IL-12B, IL-15, IL-6, TNFa) and 2 Chemokines(MCP-1, IL-8) 2) Indexes related with the stress: Zinc, calcium, Corticotropin-releasing hormone(CRH) 3) Active oxygen: Reactive oxygen species(ROS)];Metabolism biomarker [1) The metabolic hormone related with Steroidogenesis or Testosterone such as DHEA(Dehydroepiandrosterone), Androstenedione, testosterone, DHT(Dihydrotestosterone), estrone, estradiol 2) Saturated and trans fats (palmitic acid, elaidic acid), amino acids and etc. 3) The targeted bio-markers and nontargeted bio-markers associated with the Tricarboxylic Acid Cycle];Skin bio-assessment [1) SM815 sebum measuring instrument 2) ST500 infrared light thermometer 3) RVM600 skin viscosity and elasticity measuring instrument];Questionnaire [1) Diet, Menstruation (female), contraceptive pill (female), family history, smoking, Sleep 2) The pattern Instrument of Acne(PIA)]
- Secondary Outcome Measures
Name Time Method