acne
Conditions
Interventions
Group1:Oral isotretinoin 0.2 mg/kg/day once daily (qd) + topical clindamycin phosphate gel twice daily (bid)
Group2:Oral isotretinoin 0.2 mg/kg/day once daily (qd) + oral spironolactone 20 mg twice daily (bid) + topical clindamycin phosphate gel twice daily (bid)
Group3:Oral isotretinoin 0.2 mg/kg/day once daily (qd) + oral diammonium glycyrrhizinate 50 mg three times daily (tid) + topical clindamycin phosphate gel twice daily (bid)
Group4:Oral isotretinoin 0.2 mg/kg/day once daily (qd) + oral spironolactone 20 mg twice daily (bid) + oral diammonium glycyrrhizinate 50 mg three times daily (tid) + topical clindamycin phosphate gel
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with acne, with clinical severity classified as moderate-to-severe acne (grade II, III, or IV) based on the Pillsbury grading system. 2. Patients exhibiting clinical and/or biochemical hyperandrogenism: 3. Female participants aged 18-45 years; 4. Participants who can tolerate and are willing to comply with the study protocol and complete the required procedures; 5. Participants with clear contact information and who have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other endocrine disorders associated with hyperandrogenism, such as Cushing's syndrome, congenital adrenal hyperplasia, ovarian or adrenal tumors; 2. Systemic use of acne treatments such as antibiotics, isotretinoin, or traditional Chinese medicine within the past month; use of sex hormones or hormone-affecting drugs within the past month; 3. Presence of other facial skin diseases that may interfere with efficacy evaluation, such as facial psoriasis or rosacea; 4. Patients with severe internal or surgical diseases, or abnormal liver and kidney function; 5. Allergic to spironolactone, isotretinoin, or diammonium glycyrrhizinate; 6. Orthostatic hypotension, hyperkalemia, or use of other potassium-sparing diuretics; 7. Pregnant or breastfeeding women, or women planning pregnancy within the next six months; 8. Poor compliance and inability to attend follow-up visits on time; 9. Individuals with mental illnesses or those lacking legal capacity; 10. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion Clearance Rate;Global Acne Grading System (GAGS) score;Red Area Percentile in VISIA Skin Imaging System; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index;Generalized Anxiety Disorder-7;Patient Health Questionnaire-9; | — |
Countries
China
Contacts
Public ContactJianwen Ren
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed