Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.