Acne VulgarisPhase 3FASCENCT03334682
Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
A Phase 3 study testing spironolactone and Doxycycline in people with Acne Vulgaris, run by Nantes University Hospital at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- spironolactone and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 9 sitesFrance
- Study dates
- 31 Jan 2018to 4 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Chru Brest
Brest
CHU Caen
Caen
CHU Grenoble
Grenoble
CH La Rochelle
La Rochelle
CH Le Mans
Le Mans
CHU de Nantes - Dermatologie
Nantes
CHU Poitiers
Poitiers
Cabinet du Dr Jean-Paul Claudel
Tours
CHRU Tours
Tours
About this study
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:
Read more
- 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
- Being tested
- spironolactone, Doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
Dispensation of spironolactone at each visit according to the arm description described above.
DoxycyclineDrug
Dispensation of doxycycline then placebo, at each visit according to the arm description described above.
| Study group | Role | What they receive |
|---|---|---|
| spironolactone | Experimental | 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%) Receives: Drug: spironolactone |
| doxycycline | Active comparator | (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% Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- AFAST score 1: decrease of at least 2 grades compared to baseline or to grade 0 if the baseline was at 1 and
- 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).
Measured: Month 4 and Month 6
Secondary outcomes (18)
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
Measured: Within 12 months after randomization
Sodium abnormal values (biological adverse events)
Sodium measurement (mmol/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 0 (baseline) and Month 4
Inflammatory lesions of the face
Number of inflammatory lesions of the face
Measured: 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
Measured: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Face lesions
Total number of face lesions
Measured: 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.
Measured: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Relapse
number of patients with relapse, defined as follows :
- AFAST score 1 (GEA score): increase of 2 points versus score of previous visit, in case of success Or
- AFAST score 2 (mandibular score): increase of 1 point versus score of previous visit, in case of success
Measured: 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.
Measured: 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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start31 Jan 2018
- Primary completion3 Feb 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334682
- Sponsor's protocol ID
- RC16_0467
- Acronym
- FASCE
- Status last verified
- Jul 2023
- First submitted
- 30 Oct 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dreno B, Nguyen JM, Hainaut E, Machet L, Leccia MT, Beneton N, Claudel JP, Celerier P, Le Moigne M, Le Naour S, Vrignaud F, Poinas A, Dert C, Boisrobert A, Flet L, Korner S, Khammari A. Efficacy of Spironolactone Compared with Doxycycline in Moderate Acne in Adult Females: Results of the Multicentre, Controlled, Randomized, Double-blind Prospective and Parallel Female Acne Spironolactone vs doxyCycline Efficacy (FASCE) Study. Acta Derm Venereol. 2024 Feb 21;104:adv26002. doi: 10.2340/actadv.v104.26002.
PubMed 38380975Poinas A, Lemoigne M, Le Naour S, Nguyen JM, Schirr-Bonnans S, Riche VP, Vrignaud F, Machet L, Claudel JP, Leccia MT, Hainaut E, Beneton N, Dert C, Boisrobert A, Flet L, Chiffoleau A, Corvec S, Khammari A, Dreno B. FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial. Trials. 2020 Jun 25;21(1):571. doi: 10.1186/s13063-020-04432-w.
PubMed 32586344
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
- ClinicalTrials.gov ID
- NCT03334682
- Acronym / sponsor ID
- FASCE / RC16_0467
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spironolactone | Experimental | Drug: spironolactoneSpironolactone 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%) |
| doxycycline | Active comparator | Drug: Doxycycline(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% |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spironolactoneDispensation of spironolactone at each visit according to the arm description described above. | Drug | spironolactone |
| DoxycyclineDispensation of doxycycline then placebo, at each visit according to the arm description described above. | Drug | doxycycline |
Primary outcome
Treatment efficacy
Time frame: Month 4 and Month 6
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).
18 secondary outcomes
Clinical adverse events
Time frame: Within 12 months after randomization
Sodium abnormal values (biological adverse events)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Potassium abnormal values (biological adverse events)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Chlore abnormal values (biological adverse events)
Time frame: From 30 days to 7 days before randomization visit, Month 2, Month 4, Month 9
Calcium abnormal values (biological adverse events)
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
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
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
Time frame: M2, M4, M6, M9 and M12
Quality of life (cost-utility assessment and general quality of life assessment)
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
Quality of life (specific to acne)
Time frame: Month 2, Month 4, Month 6, Month 9 and Month 12
Bacterial and parasital evaluations
Time frame: Day 0 (baseline) and Month 4
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
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Face lesions
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Trunk lesions
Time frame: Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Relapse
Time frame: Month 4 and Month 6
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.
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 38380975Dreno B, Nguyen JM, Hainaut E, Machet L, Leccia MT, Beneton N, Claudel JP, Celerier P, Le Moigne M, Le Naour S, Vrignaud F, Poinas A, Dert C, Boisrobert A, Flet L, Korner S, Khammari A. Efficacy of Spironolactone Compared with Doxycycline in Moderate Acne in Adult Females: Results of the Multicentre, Controlled, Randomized, Double-blind Prospective and Parallel Female Acne Spironolactone vs doxyCycline Efficacy (FASCE) Study. Acta Derm Venereol. 2024 Feb 21;104:adv26002. doi: 10.2340/actadv.v104.26002.
- Derived from this study: PubMed 32586344Poinas A, Lemoigne M, Le Naour S, Nguyen JM, Schirr-Bonnans S, Riche VP, Vrignaud F, Machet L, Claudel JP, Leccia MT, Hainaut E, Beneton N, Dert C, Boisrobert A, Flet L, Chiffoleau A, Corvec S, Khammari A, Dreno B. FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial. Trials. 2020 Jun 25;21(1):571. doi: 10.1186/s13063-020-04432-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spironolactone and Doxycycline in people with Acne Vulgaris, run by Nantes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: Month 4 and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334682, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.