Randomized double-blind study on the benefit of spironolactone for treating acne of adult woma
- Conditions
- Acne vulgaris of adult womanMedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-001392-22-FR
- Lead Sponsor
- CHU de Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
• Female patient = 20 years old
• Patient with acne, with at least 10 inflammatory lesions and no more than 3 nodules
• Patient who already had one cycline course for her acne treatment with a 3 months wash out or who never had any cycline
• Patient having signed an informed consent
• Absence of use of oral antibiotics and Zinc salts in the last 30 days
• Absence of use of systemic isotretinoin and antiandrogens in the last 6 months
• Absence of microphysiotherapy in the last 15 days
• Women of child-bearing age under contraception at least 3 months (oral contraception, implant or IUD).
• Patients with social security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patient affected by active /progressive diseases, as infections including Hidradenitis suppurativa, cancers, or endocrine syndrome (eg polycystic ovary syndrome), Addison’s disease)
• Patient affected by Rosacea
• Patient with contra-indication to the use of one of the investigational products or auxiliary :
oPatient with intolerance or hypersensitivity to cyclin’s, spironolactone or to any ingredient present in associated benzoyl peroxide gel
oPatient with significant impairment of renal excretory function, acute or chronic renal failure, anuria.
oPatient with life-threatening or very severe hepatic impairment.(grade III or IV)
• Patient with hyperkalaemia or strongly requiring potassium-sparing diuretics (eg amiloride, canrenoate, eplerenone, triamterene), or treated continuously with ACE inhibitors, angiotensin II antagonist, NSAIDs, heparin and molecular weight heparin, ciclosporin and tacrolimus.
• Patient requiring topical isotretinoin or who stopped this drug since less than 2 weeks
• Patient previously treated with spironolactone
• Pregnant woman or likely to become pregnant or nursing and refusing to use an effective contraceptive method
• Patient participating in another interventional clinical trial
• Patient under guardianship or trusteeship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method