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The University of Southampton
Southampton Clinical Trials Unit

SAFA Trial

Title

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

Description

Spironolactone is a potassium-sparing diuretic that is widely used in the UK for indications including hypertension. It has been used off-license in acne affecting women for over 30 years due to its anti-androgenic properties, although there is little evidence of its benefit. If shown to be effective, spironolactone could reduce the use of antibiotics for acne, be cost-effective and would be more suitable for long-term use than other second line treatments in women.

The current trial seeks to answer the research question: Is oral spironolactone plus standard topical therapy superior to placebo plus standard topical therapy, at improving acne-related quality of life in adult women with moderate-severe persistent facial acne?

Objectives

Primary Objectives

To determine the clinical effectiveness of spironolactone compared with placebo, in addition to standard care, in the treatment of moderate or severe persistent facial acne in adult women – initial treatment response (12 weeks).

Secondary objectives

To assess the clinical effectiveness of adding spironolactone to standard topical treatment, compared with placebo and standard topical treatment, for moderate or severe persistent facial acne in adult women.
To assess the cost-effectiveness of adding spironolactone to standard topical therapy for the management of moderate or severe acne in adult women.
To assess the safety of adding spironolactone to standard topical treatment, compared with placebo and standard topical treatment, for moderate or severe persistent facial acne in adult women

Trial Design

Pragmatic multicentre double-blind randomised superiority trial with a sample size of 434.

Trial Status

Open for recruitment

Population

Women aged 18 years and over with moderate or severe persistent facial acne (facial acne of sufficient severity to warrant treatment with oral antibiotics).

Trial Team:

Senior Trial Manager:

Jacqui Nuttall

Trial Manager:

 Fay Chinnery (023 8120 5596)

Clinical Data Coordinator:

TBC

Contact information

Email: safa@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting

Email: ctu@soton.ac.uk

Fax: 0844 7740 621

Essential Trial Documents

SAFA - Dose Increase Prescription v2 18-MAR-2019

SAFA - GP Dose Update Letter v1 05-NOV-2018

SAFA - GP Letter v2 17-DEC-2018

SAFA - GP Unblinding letter v1 05-NOV-2018

SAFA - Informed Consent Form v2 17-DEC-2018

SAFA - Initial Conversation Script v1 08-FEB-2018

SAFA - Love2Shop voucher record v1 08-APR-2019

SAFA - Patient Contact Details Proforma v1 10-DEC-2018

SAFA - Patient Unblinding Letter v1 05-NOV-2018

SAFA - Patient Invitation Letter v1 05-NOV-2018

SAFA - Photograph WPD v1 15-MAR-2019

SAFA - Protocol v4 08-MAR-2019

SAFA - SAE/SUSAR Report Form v1 25-JAN-2019

SAFA - IMP Accountability Log v1 31-May-2019

ISF Documents

SAFA - Patient Screening Log v1 15-MAR-2019

SAFA - Master Patient List v1 10-DEC-2018

SAFA - Site Delegation Log v1 25-JAN-2019

SAFA - Site Visit Log v1 03-DEC-2018

Questionnaires and Crib Sheets

SAFA - Baseline crib sheet - Clinician v2 18-JAN-2019

SAFA - Baseline questionnaire - Patient v1 05-NOV-2018

SAFA - 6 week crib - Clinician v1 05-NOV-2018

SAFA - 6 week questionnaire - Patient v1 05-NOV-2018

SAFA - 12 week crib - Clinician v1 05-NOV-2018

SAFA - 12 week questionnaire - Patient v1 05-NOV-2018

SAFA - 24 week questionnaire v1 05-NOV-2018

SAFA - 52 week questionnaire v1 05-NOV-2018

SAFA - EoT-EoS form v1 05-NOV-2018

Local Headed Documents

Birmingham:

SAFA - Birmingham PIS v3 04-FEB-2019

SAFA - Birmingham Poster v1 05-NOV-2018

SAFA - Birmingham Prescription and dosing instructions v2 18-MAR-2019

SAFA - Birmingham Summary PIS v1 09-JAN-2019

Bristol: 

SAFA - Bristol PIS v3 04-FEB-2019

SAFA - Bristol Poster v1 05-NOV-2018

SAFA - Bristol Prescription and dosing instructions v2 18-MAR-2019

SAFA - Bristol Summary PIS v1 09-JAN-2019

Harrogate: 

SAFA - Harrogate PIS v3 04-FEB-2019

SAFA - Harrogate Poster v1 05-NOV-2018

SAFA - Harrogate Prescription and dosing instructions v2 18-MAR-2019

SAFA - Harrogate Summary PIS v1 09-JAN-2019

Poole: 

SAFA - Poole PIS v3 04-FEB-2019

SAFA - Poole Poster v1 05-NOV-2018

SAFA - Poole Prescription and dosing instructions v2 18-MAR-2019

SAFA - Poole Summary PIS v1 09-JAN-2019

Portsmouth: 

SAFA - Portsmouth PIS v3 04-FEB-2019

SAFA - Portsmouth Poster v1 05-NOV-2018

SAFA - Portsmouth Prescription and dosing instructions v2 01-May-2019

SAFA - Portsmouth Summary PIS v1 09-JAN-2019

SAFA - Portsmouth Subject Accountability Log v1 

SAFA - Portsmouth Trial IMP Accountability Log v1

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