Spironolactone for Adult Female Acne

Phase 1

• Conditions: Acne of sufficient severity to warrant treatment with oral antibiotics.; MedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-003630-33-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-08
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 434

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified