Acne
Conditions
Interventions
Test group:The administration method of isotretinoin is 20mg/d, with a frequency of once a day (QD) or twice a day (BID), taken with meals for 24 weeks. The low-molecular-weight heparin sodium gel was
Control group:The administration method of isotretinoin is 20mg/d, with a frequency of once a day (QD) or twice a day (BID), taken with meals for 24 weeks.
Sponsors
The Fifth Affiliated Hospital of Sun Yat sen University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for moderate to severe acne vulgaris: Subject Investigator's Overall Assessment (IGA) score of grade 3 or 4, and cyst count = 3; 2. Age range of 18-40 years old; 3. Men with fertility and women of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form until 3 months after the last administration of the experimental drug; 4. Voluntarily sign the informed consent form; 5. The subjects are willing and able to complete the study, understand and comply with the study requirements, abide by the limitations and education of the study requirements, use the investigational drugs according to medical advice, and follow up according to the study plan.
Exclusion criteria
Exclusion criteria: 1. Those who cannot persist in follow-up visits; 2. Pregnant, preconception, and lactating women; 3. Patients with any serious clinical system disease history/surgery history, such as digestive system, circulatory system, nervous system, blood system, immune system, mental system diseases, or those who are evaluated by the researcher as not suitable for oral isotretinoin treatment due to the combination of other systemic active diseases, such as liver and kidney dysfunction, malignant tumors, inflammatory bowel disease, diabetes, obesity, hyperlipidemia, lipid metabolism disorders, coagulation dysfunction, etc; 4. Individuals who are allergic to experimental drugs (including heparin and isotretinoin); 5. During the experiment, exposure to sunlight, excessive drinking, and drug abuse were unavoidable; 6. Other obvious skin diseases that may affect the efficacy evaluation of facial acne or require joint treatment at the affected area, such as photodermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, atopic dermatitis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 24, the percentage change in total skin lesion count compared to baseline for each group of subjects.; | — |
Secondary
| Measure | Time frame |
|---|---|
| At week 24, the percentage of researchers' overall assessment (IGA) treatment success for each group of subjects; | — |
Countries
China
Contacts
Public ContactHan Ma
The Fifth Affiliated Hospital of Sun Yat sen University
Outcome results
None listed