Spironolactone for Adult Female Acne: A pragmatic multicentre double-blind randomised superiority trial to investigate the clinical and cost-effectiveness of spironolactone for moderate or severe persistent acne in women - Spironolactone for Adult Female Acne

niversity of Southampton0 个研究点目标入组 434 人开始时间: 2019年11月8日最近更新: 2020年4月29日

试验速览

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•- Women aged 18 years or over
•- Facial acne, symptoms present since at least 6 months
•- Acne of sufficient severity to warrant treatment with oral antibiotics, as judged by the study clinician
•- Women of childbearing potential at risk of pregnancy must be willing to use their usual hormonal or barrier method of contraception for the first 6 months of the study
•- Willing to be randomised to either study group
•- Willing and able to give informed consent
•- Sufficient English to carry out primary outcome Acne-QoL (which has not been validated in other languages)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 433
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- Serum potassium above the upper limit of the reference range for the laboratory processing the test (measured at the baseline clinic visit)
•- eGFR below 60 ml/min/1.73m2
•- Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
•- Acne grade 0-1 using the Investigator’s Global Assessment (i.e. clear or almost clear)
•- Currently taking potassium-sparing diuretic, ACE inhibitor, angiotensin II receptor blocker or digoxin
•- Started, stopped or changed long-term (lasting more than 2 weeks) hormonal contraception, co-cyprindiol or other hormonal treatment within the past 3 months
•- Planning to start, stop or change long-term hormonal contraception, co-cyprindiol or other hormonal treatment within the next 3 months
•- Pregnant/breastfeeding
•- Intending to become pregnant in the next 6 months
•- Androgen-secreting adrenal or ovarian tumour
•- Cushing’s syndrome
•- Congenital adrenal hyperplasia
•- Oral antibiotic treatment (lasting longer than a week) for acne within the past month
•- Oral isotretinoin treatment within the past 6 months

发起方

niversity of Southampton