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
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Among 24 studies in Acne Vulgaris with a site in France — 3 open to participants now, 4 under way, 1 of them phase 3. Acne Vulgaris · France.
Among the 24 studies in Acne Vulgaris with a site in France, this one is the 5th largest by enrollment of the 18 interventional ones that give a count, is one of 4 that started in 2018, is one of 3 in phase 3, and was the 7th registered.
791 studies on the registry are indexed under Acne Vulgaris; 94 are open to participants now.
Browse Acne Vulgaris studies →3 of the 24 studies in Acne Vulgaris with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire de Nice · Sites in France, French Guiana
Ages 13–30
Eurofeedback · Sites in France
Ages 18+ · Healthy volunteers
Nantes University Hospital · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 47 Acne Vulgaris studies recruiting now, 17 (36%) set no upper age limit and 29 (62%) stop at 75 or younger; 21 take children under 18; 17 take healthy volunteers.
This study: 20 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 158 is above the median of 70 across 673 interventional studies indexed under Acne Vulgaris.
Median enrollment 78 across the 18 interventional studies, 127 across the 6 observational. Of the 18 that completed or were terminated, 6 (33%) have results posted.
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19 of 24 have an industry lead sponsor. The 10 most frequent:
Nantes University Hospital is the lead sponsor of 839 studies on the registry; 191 are open to participants now.
Nantes University Hospital has 2 studies filed under Acne Vulgaris — fewer than ten, so there is no comparison to draw.
1 of the studies in Acne Vulgaris with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06447480Phase 3Centre Hospitalier Universitaire de NiceClinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients | 2027-09-01 |
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Among the 24 studies in Acne Vulgaris with a site in France, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient with to the use of one of the products or auxiliary :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jan 2018 to primary completion in Feb 2023, 60 months.
Of 62 phase 3 interventional studies under Acne Vulgaris, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 17. This study's 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spironolactone