Spironolactone with Fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO) compared to Doxycycline with Fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO) for moderate to severe acne vulgaris in female patients

Phase 3

Recruiting

• Conditions: Moderate to severe acne vulgaris Female patients 18- 45 years old; Acne vulgaris; Fixed- dose combination adapalene 0.1%/benzoyl peroxide 2.5% (A/BPO); Doxycycline; Spironolactone

• Registration Number: TCTR20200805006
• Lead Sponsor: Ratchadaphiseksomphot Endowment Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-05
• Study Completion: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences of percent changes of total number of acne vulgaris 3 months Total number of acne vulgaris

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve score 0-1 at 3 months 3 months Clinical gradings : Investigator global evaluation acne (IGEA)