A Phase 3 interventional study of spironolactone and Doxycycline in Acne Vulgaris, sponsored by Nantes University Hospital. Completed at 9 sites in France. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Patient with contra-indication to the use of one of the investigational products or auxiliary :
Spironolactone ARROW ® 75 mg, 150mg, orally, once a day during all the trial (12 months: 6 months on double-blinded spironolactone then 6 months on open-label spironolactone), + topical therapy during all the trial (benzoyl peroxide 5%)
Drug: spironolactone
(Doxycycline Sandoz 100 mg), 100mg/day during 3 months followed by placebo during 3 months, on double-blinded + topical therapy during all the trial (benzoyl peroxide 5%
Drug: Doxycycline
Dispensation of spironolactone at each visit according to the arm description described above.
Dispensation of doxycycline then placebo, at each visit according to the arm description described above.
Treatment efficacy
The treatment's efficacy will be determined by the rate of success in each arm. The best rate of success between Month 4 and Month 6 will be chosen for the final result. Rate of success, defined by a decrease of both Adult Female Acne Scoring Tool (AFAST) scores 1 and 2: 1. AFAST score 1: decrease of at least 2 grades compared to baseline or to grade 0 if the baseline was at 1 and 2. AFAST score 2: decrease to grade 1 if baseline was \> 1 or to grade 0 if the baseline was at 1 AFAST 1 (also called GEA) assesses the comedones (open and closed), the non-inflammatory lesions, the papules and pustules and the nodules. The stage is defined according to a global evaluation of severity of acne and ranges from Grade 0 (no acne) to Grade 5 (the worse situation). AFAST 2 assesses acne on an area from the left and right mandibular zone to the upper edge of the trunk and ranges from Grade 0 (no acne) to Grade 3 (the worse situation).
Time frame: Month 4 and Month 6
Clinical adverse events
Number and type of Adverse Events (AE) and Serious Adverse Events (SAE) occurring from the beginning of the treatment until end of the follow-up
Time frame: Within 12 months after randomization
Sodium abnormal values (biological adverse events)
Sodium measurement (mmol/L)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Potassium abnormal values (biological adverse events)
potassium measurement (mmol/L)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Chlore abnormal values (biological adverse events)
Chlore measurement (mmol/L)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Calcium abnormal values (biological adverse events)
Calcium measurement (mmol/L)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
AFAST score 1 (GEA) at 0 or 1
Number of patients with AFAST score 1 (GEA) at 0 or 1.
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
AFAST score 2 (Mandibular) at 0 or 1
Number of patients with AFAST score 2 (Mandibular) at 0 or 1.
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
AFAST score 1 associated with AFAST score 2 at 0 or 1
Number of patients with both AFAST score 1 and AFAST score 2 at 0 or 1.
Time frame: M2, M4, M6, M9 and M12
Quality of life (cost-utility assessment and general quality of life assessment)
EQ-5D (EuroQol 5 dimensions) questionnaire: The questionnaire focuses on five dimensions: mobility, personal autonomy, current activities, pain/discomfort, and anxiety/depression. For each of these dimensions, three answers are possible.
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
Quality of life (specific to acne)
Cardiff Acne disability Index (CADI) is a disease-specific questionnaire measuring disability induced by acne.
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
Bacterial and parasital evaluations
Presence of P acnes, M Furfur and S epidermidis, aureus
Time frame: Day 0 (baseline) and Month 4
Inflammatory lesions of the face
Number of inflammatory lesions of the face
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
retentional lesions of the face
Number of retentional lesions of the face
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Face lesions
Total number of face lesions
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Trunk lesions
Factor F2 of ECLA scale ECLA ("Echelle de Cotation des Lésions d'Acné") is a scale for acne proposed by the dermatology research team of Nantes University Hospital. It is composed of 3 factors: Factor 1 (F1) counts the acne lesions on the face; Factor 2 (F2) counts the lesions acne on the trunk and Factor 3 (F3) counts the scars. In this study, the factor F2 will be used. The factor F2 assesses the extensive character of acne lesions on 5 defined areas: cervical areas (F2N); chest areas (F2C); back area (F2B) and arm area (F2A) according to a qualitative scale 0=absent, 1=poor 2=medium 3=significant. It is completed by the count of the present nodules in each area.
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Relapse
number of patients with relapse, defined as follows : 1. AFAST score 1 (GEA score): increase of 2 points versus score of previous visit, in case of success Or 2. AFAST score 2 (mandibular score): increase of 1 point versus score of previous visit, in case of success
Time frame: Month 4 and Month 6
Reappearance of 10% and more of inflammatory lesions.
Number of patients with a reappearance of 10% and more of inflammatory lesions.
Time frame: Month 6
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) of the comparison between the spironolactone and cycline.
costs: resources consumed, QALY: EQ-5D
Time frame: Month 6
Plan to share: No
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Nantes University Hospital