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About
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 essentially 2 factors:
On a therapeutic plan, four types of systemic treatment, approved in this indication are:
In this context, the spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH) production at the pituitary level. It is not submitted to isotretinoin constraints, does not lead to bacterial resistance and targets the peripheral hyperandrogenism.
Currently, very few studies have been performed and on a weak number of patients but they showed that at low doses (lower than 200mg/day), spironolactone can be effective against acne.
In that context, it seemed clearly interesting to perform the first double-blind randomized study spironolactone vs cyclines which remains the moderate acne reference treatment and to demonstrate the superiority of spironolactone's efficacy in order to establish it as alternative way to cycline.
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Inclusion criteria
Exclusion criteria
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 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
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158 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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