Status:
COMPLETED
Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
Lead Sponsor:
Nantes University Hospital
Conditions:
Acne Vulgaris
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief Summary
Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20% to 30% of adult women. The physiopathology of adult woman acne is distinguished from the teenager one by es...
Eligibility Criteria
Inclusion
- 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 da
- Women of child-bearing age under contraception since 3 months (oral contraception, implant or IUD).
- Patients with social security
Exclusion
- 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 :
- Patient with intolerance or hypersensitivity to cyclin's, 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 with hyperkalaemia or strongly requiring potassium-sparing diuretics (eg amiloride, canrenoate, eplerenone, triamterene), or treated continuously with Angiotensin-converting-enzyme (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
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2023
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03334682
Start Date
January 31 2018
End Date
July 4 2023
Last Update
July 18 2023
Active Locations (9)
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1
Chru Brest
Brest, France
2
CHU Caen
Caen, France
3
CHU Grenoble
Grenoble, France
4
CH La Rochelle
La Rochelle, France