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

July 17, 2023 updated by: Nantes University Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHRU Brest
      • Caen, France
        • CHU CAEN
      • Grenoble, France
        • CHU Grenoble
      • La Rochelle, France
        • CH La Rochelle
      • Le Mans, France
        • CH Le Mans
      • Nantes, France
        • CHU de Nantes - Dermatologie
      • Poitiers, France
        • CHU Poitiers
      • Tours, France
        • CHRU TOURS
      • Tours, France
        • Cabinet du Dr Jean-Paul Claudel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: spironolactone
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
Dispensation of spironolactone at each visit according to the arm description described above.
Active Comparator: 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%
Drug: Doxycycline
Dispensation of doxycycline then placebo, at each visit according to the arm description described above.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Month 4 and Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical adverse events
Time Frame: Within 12 months after randomization
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
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
Sodium measurement (mmol/L)
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
potassium measurement (mmol/L)
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
Chlore measurement (mmol/L)
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
Calcium measurement (mmol/L)
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
Number of patients with AFAST score 1 (GEA) at 0 or 1.
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
Number of patients with AFAST score 2 (Mandibular) at 0 or 1.
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
Number of patients with both AFAST score 1 and AFAST score 2 at 0 or 1.
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
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.
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
Cardiff Acne disability Index (CADI) is a disease-specific questionnaire measuring disability induced by acne.
Month 2, Month 4, Month 6, Month 9 and Month 12
Bacterial and parasital evaluations
Time Frame: Day 0 (baseline) and Month 4
Presence of P acnes, M Furfur and S epidermidis, aureus
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
Number of inflammatory lesions of the face
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
Number of retentional lesions of the face
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
Total number of face lesions
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
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.
Day 0 (baseline), Month 2, Month 4, Month 6, Month 9 and Month 12
Relapse
Time Frame: Month 4 and Month 6

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
Month 4 and Month 6
Reappearance of 10% and more of inflammatory lesions.
Time Frame: Month 6
Number of patients with a reappearance of 10% and more of inflammatory lesions.
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
costs: resources consumed, QALY: EQ-5D
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC16_0467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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