ISRCTN12892056已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
研究概览
简要总结
2021 Protocol article in http://dx.doi.org/10.1136/bmjopen-2021-053876 (added 27/08/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37192767/ results (added 17/05/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37821899/ Qualitative interview study (added 12/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38081673/ Health economic evaluation (added 18/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •2. Aged 18 years or over
- •3. Facial acne with symptoms present since at least 6 months
- •4. Acne of sufficient severity to warrant treatment with oral antibiotics, as judged by the study clinician
- •5. 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
- •6. Willing to be randomised to either study arm
- •7. Willing and able to give informed consent
- •8. Sufficient English to carry out primary outcome Acne-QoL (which has not been validated in other languages)
排除标准
- •Current exclusion criteria as of 20/01/2020:
- •1. Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •2. Acne grade 0-1 using the Investigator’s Global Assessment (i.e. clear or almost clear)
- •3. Currently using any of the following:
- •3.1. Potassium-sparing diuretic
- •3.2. ACE inhibitor
- •3.3. Angiotensin II receptor blocker
- •3.4. Digoxin
- •4. Started, stopped or changed long-term (lasting more than 2 weeks) hormonal contraception, co-cyprindiol or other hormonal treatment within the past 3 months
- •5. Planning to start, stop or change long-term (lasting more than 2 weeks) hormonal
- •contraception, co-cyprindiol or other hormonal treatment within the next 3 months
- •6. Pregnant/breastfeeding
- •7. Intending to become pregnant in the next 6 months
- •8. Androgen-secreting adrenal or ovarian tumour
- •9. Cushing’s syndrome
- •10. Congenital adrenal hyperplasia
- •11. Oral antibiotic treatment (lasting longer than a week) for acne within the past month
- •12. Oral isotretinoin treatment within the past 6 months
- •13. Has ever used spironolactone
- •Blood tests will also be performed at baseline to determine participants’ serum potassium level and estimated glomerular filtration rate (eGFR). Participants may start the trial IMP before the test results are known.
- •STOPPING CRITERIA
- •Participants may commence treatment before blood test results are known, but if there is an abnormality (serum potassium level is above the upper limit of the reference range for the laboratory processing the sample, or the eGFR is below 60 ml/min/1.73m2), the participant must be contacted within 5 working days by telephone and told to stop taking the IMP. Participant will be considered a screen failure.
- •Previous exclusion criteria:
- •1. Serum potassium above the upper limit of the reference range for the laboratory processing the test (measured at the baseline clinic visit)
- •2. eGFR below 60 ml/min/1.73m²
- •3. Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •4. Acne grade 0-1 using the Investigator’s Global Assessment (i.e. clear or almost clear)
- •5. Currently using any of the following:
- •5.1. Potassium-sparing diuretic
- •5.2. ACE inhibitor
- •5.3. Angiotensin II receptor blocker
- •5.4. Digoxin
- •6. Started, stopped or changed long-term (lasting more than 2 weeks) hormonal contraception, co-cyprindiol or other hormonal treatment within the past 3 months
- •7. Planning to start, stop or change long-term (lasting more than 2 weeks) hormonal contraception, co-cyprindiol or other hormonal treatment within the next 3 months
- •8. Pregnant/breastfeeding
- •9. Intending to become pregnant in the next 6 months
- •10. Androgen-secreting adrenal or ovarian tumour
- •11. Cushing’s syndrome
- •12. Congenital adrenal hyperplasia
- •13. Oral antibiotic treatment (lasting longer than a week) for acne within the past month
- •14. Oral isotretinoin treatment within the past 6 months
- •Added 25/04/2019:
- •15. Has ever used spironolactone
研究者
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