Moderate to severe acne vulgaris Female patients 18-
Conditions
Interventions
Spironolactone with Fixed-
dose combination adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO) ,Doxycycline with Fixed-
dose combination adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO)
Active Comparator Drug,Active Comparator Drug
Spironolactone,Doxycycline
Sponsors
Ratchadaphiseksomphot Endowment Fund
Faculty of Medicine,
Chulalongkorn university
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female patients 18-45 years old 2. Moderate to severe acne vulgaris 3. Did not use Topical retinoid, Benzoyl peroxide, Azelaic acid, or Salicylic acid within 1 month 4. Did not use Oral antibiotics (Doxycycline, Tetracycline, Minocycline), Oral retinoid, Antiandrogen, or Oral contraceptive pills within 3 months 5. Regular cycle (Interval 21-35 days) 6. Good compliance (Can visit every follow up) 7. Sign consent form
Exclusion criteria
Exclusion criteria: 1. Immunodeficiency (According to history taking and medical records) HIV patients, AIDS 2. Gynecologic conditions (According to history taking and medical records) Endometriosis, Polycystic ovarian syndrome, Ovarian cyst, Gynecologic cancer 3. Pregnant and lactating women 4. Allergy to Doxycycline, Spironolactone, or Epiduo® 5. Chronic kidney disease (Creatinine at the first day of inclusion > 1.4) 6. Serum potassium at the first day of inclusion > 5 7. Systolic blood pressure < 90, or Diastolic blood pressure < 60
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences of percent changes of total number of acne vulgaris 3 months Total number of acne vulgaris | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve score 0-1 at 3 months 3 months Clinical gradings : Investigator global evaluation acne (IGEA) | — |
Countries
Thailand
Contacts
Public ContactChanat Kumtornrut
Chulalongkorn university
Outcome results
None listed