SAFA

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 SAFA 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

Closed

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).

Contact Details

All trial enquiries should be sent to ctu@soton.ac.uk

Publications

Renz S, Chinnery F, Stuart B, et al. Spironolactone for adult female acne (SAFA): protocol for a double-blind, placebo-controlled, phase III randomised study of spironolactone as systemic therapy for acne in adult women. BMJ Open 2021;11:e053876. doi: 10.1136/bmjopen-2021-053876

Other Media

Daily Mail, 14.09.21 (second story down)

Funder

This trial was finded by an NIHR Health Teachnology Assessment (HTA) grant (reference no. NIHR16/13/02)