Moderate and severe acne vulgaris Skin and Connective Tissue Diseases Acne vulgaris
Conditions
Interventions
The healthy volunteers do not receive any treatment. All patients are randomized (using a computational random grouping table made by IBM SPSS Statistics 21.0) to oral isotretinoin in combination with
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who meet the criteria for diagnosis and classification of moderate and severe acne vulgaris or healthy volunteers 2. Male or female, at least 18 years of age, maximum age 30 years 3. Body mass index (BMI) 18-25 kg/m² 4. No isotretinoin and ?-3 fatty acids were taken orally within 6 months 5. No drugs were systematically applied within 6 months 6. Participants who have signed the informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with other skin diseases. 2. Participants with immune deficiency or other immune diseases 3. Participants with metabolic diseases such as diabetes and hyperlipidemia 4. Participants with tumors and other serious medical diseases 5. Smokers and alcoholics 6. Pregnant and lactating women 7. Participants who had undergone gastrointestinal surgery 8. Participants with the allergic constitution 9. Participants who known to be allergic to isotretinoin and ?-3 fatty acids 10. Participants who refuse to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16s rDNA sequence measured from fresh fecal sample at baseline and after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease severity of acne vulgaris measured using the Global Acne Grading System (GAGS) at baseline and after 12 weeks of treatment 2. The percentage of red area and porphyrins on the front, left and right sides measured respectively using the VISIA-CR™ imaging system at baseline and after 12 weeks of treatment 3. The levels of blood glucose, cholesterol, triglyceride, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) from fasting venous blood measured enzymatically with an automatic analyser at baseline and after 12 weeks of treatment 4. Fasting insulin measured using ELISA at baseline and after 12 weeks of treatment 5. Insulin resistance measured using the homeostasis model assessment of insulin resistance (HOMA-IR) at baseline and after 12 weeks of treatment 6. Serum sample collected for liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis at baseline and after 12 weeks of treatment | — |
Countries
China
Outcome results
None listed