Acne vulgaris of adult woman MedDRA version: 20.0 Level: PT Classification code 10000496 Term: Acne System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Spironolactone Arrow 75mg
Product Name: spironolactone
Pharmaceutical Form: Capsule
INN or Proposed INN: Spironolactone
Other descriptive name: SPIRONOLACTONE
Concentration unit: mg millig
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female patient = 20 years old • 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 days • Women of child-bearing age under contraception at least 3 months (oral contraception, implant or IUD). • Patients with social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 : o Patient with intolerance or hypersensitivity to cyclin’s, spironolactone or to any ingredient present in associated benzoyl peroxide gel o Patient with significant impairment of renal excretory function, acute or chronic renal failure, anuria. o 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to demonstrate the superiority of spironolactone’s efficacy in adult female acne compared to the doxycycline (reference treatment).;Secondary Objective: 1)The safety (clinical and biological) 2)The percentage of patients having AFAST score 1 (GEA) at 0 or 1 3)The percentage of patients having AFAST score 2 (mendibular) at 0 or 1 4)Complete remission 5)The Quality of Life 6)Comparison of P acnes, M Furfur and S epidermidis, aureus 7)Comparison of inflammatory lesions of the face 8)Comparison of retentional lesions of the face 9)Comparison of the number of face lesions between 10)Comparison of the trunk lesions (Factor F2 of ECLA) 11)Comparison of the percentage of patients’ relapse 12)Comparison of the percentage of reappearance of 10% and more of inflammatory lesions 13)Cost-effectiveness analysis (economic efficiency analysis) of spironolactone versus doxycycline ;Primary end point(s): The treatment’s efficacy will be determined by the rate of success in each arm. This rate of success is defined by a decrease of both AFAST scores 1 and 2: 1°) AFAST score 1 (corresponding to GEA score): decrease of at least 2 grades compared to baseline or to grade 0 if the baseline was at 1 and 2°) AFAST score 2 (mandibular score): decrease to grade 1 if baseline was > 1 or to grade 0 if the baseline was at 1 ;Timepoint(s) of evaluation of this end point: M4 and M6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Number and type of AE and SAE 1bis) Abnormal values of ionogram 2)Number of patients with AFAST score 1 (GEA) at 0 or 1 3)Number of patients with AFAST score 2 (Mandibular) at 0 or 1 4)Number of patients with both AFAST score 1 and AFAST score 2 at 0 or 1 5)Quality of life questionnaire EQ-5D and index of quality of life in Acne (CADI) 6)Bacterial and parasital sampling 7)Number of inflammatory lesions of the face 8)Number of retentional lesions of the face 9)Number of face lesions 10)Number of trunk lesions (Factor F2 of ECLA) 11)Number of patients with relapse Relapse is 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 12)Number of patients with a reappearance of 10% and more of inflammatory lesions 13)Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) of the comparison between the spironolactone and cycline ;Timepoint(s) of evaluation of this end point: 1- up to 12 months of follow-up 1bis- at D0, M4 and M9 2- 3- 4- 5- at M2, M4, M6, M9 and M12 6- at D0 and M4 7- 8- 9-10- at D0 (baseline), M2, M4, M6 M9 and M12 11- M4 and M6 12- at M6 13- at M6 | — |
Countries
France
Contacts
Public ContactDirection de la Recherche
CHU de Nantes
Outcome results
None listed