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Table 1 Inclusion and non-inclusion criteria of the FASCE trial

From: FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial

Inclusion criteriaNon-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
  1. GEA Global Evaluation Assessment, ACE angiotensin-converting enzyme, NSAID non-steroidal anti-inflammatory drug, IUD intra-uterine device