Spironolactone for adult female acne

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 410

Inclusion Criteria

1. Female
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)

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life, assessed using the Acne-QoL symptom subscale score at 12 weeks

Secondary Outcome Measures

Name	Time	Method

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