Acne Skin and Connective Tissue Diseases Adult female acne
Conditions
Interventions
Participants will be randomised to a patient pack which will contain either spironolactone or the placebo in a 1:1 ratio using an Interactive Web Response System (IWRS). Participants will be stratifie
Sponsors
University of Southampton
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life, assessed using the Acne-QoL symptom subscale score at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life, assessed using the Acne-QoL symptom subscale score at 6 and 24 weeks 2. Emotional effect of the impact of facial acne, assessed using the role-emotional subscale of the Acne-QoL at 6, 12 and 24 weeks 3. Impact of facial acne on a respondent's intersocial relationships, assessed using the role-emotional subscale of the Acne-QoL at 6, 12 and 24 weeks 4. Self-perception of facial acne, assessed using the role-emotional subscale of the Acne-QoL at 6, 12 and 24 weeks 5. Participant self-assessed improvement,recorded on a 6-point Likert scale (with baseline photograph to assist recall) at 6, 12 and 24 weeks 6. Description of individual's acne, assessed by the treating clinician using the Investigator’s Global Assessment at 6 and 12 weeks, adjusted for baseline variables 7. Description of individual's acne, assessed by the individual themselves using the Participant’s Global Assessment at 6, 12 and 24 weeks, adjusted for baseline variables 8. Participant satisfaction with study treatment at 24 weeks (asked prior to unblinding), assessed using a 6-point Likert scale 9. Health-related quality of life, assessed using the EQ-5D-5L at 6, 12 and 24 weeks 10. Cost and cost-effectiveness, assessed using: 10.1. eCRF (case report form) regarding the intervention at the baseline and 6, 12, 24 and 52 weeks 10.2. Participant questionnaires regarding wider NHS resource use at the baseline and 6, 12, 24 and 52 weeks 10.3. EQ-5D-5L at the baseline and 6, 12, 24 and 52 weeks 10.4. Quality adjusted life years (QALYs), assessed using the EQ-5D-5L at the baseline and 6, 12, 24 and 52 weeks The primary economic evaluation will be an Incremental cost utility analysis from an NHS perspective, as this enables the cost effectiveness to be compared across a range of health conditions and interventions such that decision makers can use the information to inform prioritisation of health care. A detailed Health Economic Analysis Plan will be written and reviewed prior to the tri | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactFay Chinnery
Outcome results
None listed