NCT03334682

Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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 essentially 2 factors: * hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of cutaneous androgens receptors of these women. But this point is still at the stage of hypothesis. * inflammatory factor linked with Propionibacterium Aces ; indeed these women received most of the time many cures of local and systematic antibiotics at the origin of resistant Propionibacterium Aces strains which lead to a chronical activation of cutaneous innate immunity. On a therapeutic plan, four types of systemic treatment, approved in this indication are: * Tetracyclines which are problematic for the bacterial resistance and consequently constant relapse when they are stopped. * Zinc salts which target only the inflammatory lesions and were shown less effective than cycline * Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance. * The last alternative is represented by isotretinoin but the use in women of childbearing potential is binding because of the teratogen risks and the hyperandrogenism represents an identified risk of relapse. 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	spironolactone	Dispensation of spironolactone at each visit according to the arm description described above.
DRUG	Doxycycline	Dispensation of doxycycline then placebo, at each visit according to the arm description described above.

Timeline

• Start date: 2018-01-31
• Primary completion: 2023-02-03
• Completion: 2023-07-04
• First posted: 2017-11-07
• Last updated: 2023-07-18

Locations

9 sites across 1 country: France