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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    200
  • sponsor
    Nantes University Hospital
Updated on 23 January 2021
doxycycline
antibiotics
acne treatment
isotretinoin
pituitary
androgens

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.

Details
Condition Acne Vulgaris, Acne, acnes
Treatment doxycycline, Spironolactone
Clinical Study IdentifierNCT03334682
SponsorNantes University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Are you female?
Do you have any of these conditions: Acne or Acne Vulgaris?
Do you have any of these conditions: Acne Vulgaris or Acne or acnes?
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 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 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
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