Table 1 Inclusion and non-inclusion criteria of the FASCE trial
Inclusion criteria | Non-inclusion criteria |
|---|---|
• Female patient ≥ 20 years old | • Patient affected by active/progressive diseases, as infections including hidradenitis suppurativa, cancers or endocrine syndrome (e.g. polycystic ovary syndrome), Addison’s disease) |
• Patient with acne, with at least 10 inflammatory lesions and no more than 3 nodules (GEA score between 2 and 4) | • Patient affected by rosacea (folliculitis) |
• Patient who already had one cycline course for her acne treatment with a 3-month* wash out or who never took any cyclines | • Patient with contra-indication to the use of one of the investigational products or auxiliary: ◦ Patient with intolerance or hypersensitivity to cyclines, spironolactone or to any ingredient present in associated benzoyl peroxide gel ◦ Patient with significant impairment of renal excretory function, acute or chronic renal failure, anuria ◦ Patient with life-threatening or very severe hepatic impairment. (grade III or IV) |
• Patient having signed an informed consent | • Patient with hyperkalaemia or strongly requiring potassium-sparing diuretics (e.g. amiloride, canrenoate, eplerenone, triamterene) or treated continuously with ACE inhibitors, angiotensin II antagonist, NSAIDs, heparin and molecular-weight heparin, ciclosporin and tacrolimus, or treated with lithium |
• Absence of use of oral antibiotics and zinc salts in the last 30 days | • Patient requiring topical isotretinoin or who stopped this drug less than 2 weeks ago |
• Absence of use of topical antibiotics in the last 15 days | • Association with potassium salts except in the case of hypokalaemia |
• Absence of use of systemic isotretinoin and antiandrogens in the last 6 months (but antiandrogens used as contraceptive are authorized) | • Patient previously treated with spironolactone |
• Absence of microphysiotherapy in the last 15 days | • Pregnant woman or likely to become pregnant or nursing and refusing to use an effective contraceptive method |
• Women of child-bearing age under contraception for 3 months (oral contraception, implant, IUD or other kind of hormonal contraception) | • Patient participating in another interventional clinical trial |
• Patients with social security | • Patient under guardianship or trusteeship |