# Comparative effectiveness of spironolactone versus oral tetracycline-class antibiotics for the treatment of moderate to severe acne in women

> **NIH NIH R34** · UNIVERSITY OF PENNSYLVANIA · 2020 · $142,560

## Abstract

Project Summary/Abstract
 Acne is one of the most common diseases worldwide, affecting 85% of adolescents and often persisting
into adulthood. Acne is responsible for a greater global burden of disease than psoriasis, cellulitis, and
melanoma. While mild acne can usually be managed with topical medications, moderate to severe acne often
requires treatment with systemic agents such as oral antibiotics, hormonal therapies, and isotretinoin.
Remarkably, while these agents are a standard part of care, there are very few randomized clinical trials
showing efficacy and none that show comparative effectiveness between these commonly used agents; the
Institute of Medicine has identified this area as one of the top priorities for comparative effectiveness research.
 Previous work by our group has shown oral antibiotics are the most common systemic agent used in the
treatment of acne and patients frequently use them for more than one year. In fact, dermatologists prescribe
more antibiotics per capita than any other specialty. However, prolonged antibiotic use may be associated with
a variety of adverse outcomes including bacterial antibiotic resistance, pharyngitis, collagen vascular illnesses,
inflammatory bowel disease, and breast and colon cancer. As a result, there is growing international interest
and attention specifically from the Centers for Disease Control regarding improving antibiotic stewardship in
the outpatient setting and multiple clinical guidelines for acne have recommended reducing the use of
antibiotics through the use of non-antimicrobial therapies and by limiting the duration of therapy.
 For women with moderate to severe acne, spironolactone may represent an effective, well-tolerated
alternative to oral antibiotics. Developed as a potassium-sparing diuretic, for many years it has also been used
off-label for acne due to its impact on hormonal pathogenesis of this disease. However, despite expert opinion
supporting the use of spironolactone in the treatment of acne, its use remains relatively uncommon and clinical
evidence demonstrating the effectiveness of spironolactone is limited to small, often retrospective studies.
Trials comparing the effectiveness of spironolactone to that of other agents such as oral antibiotics are lacking.
 Our ultimate goal is to complete the necessary planning and preparation to conduct a novel, prospective,
randomized clinical trial evaluating the comparative effectiveness of spironolactone and oral tetracycline-class
antibiotics in the treatment of acne in adult women. No such study has previously been conducted. The results
of this study would have substantial implications for the treatment of acne and antibiotic stewardship. In
addition, this study may allow us to monitor for the timing of the development of antibiotic resistance in a
healthy population of patients treated with extended courses of antibiotics and to evaluate the impact of
prolonged exposure to oral antibiotics on the microbiome. Our pr...

## Key facts

- **NIH application ID:** 9969338
- **Project number:** 5R34AR074733-02
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** David Joel Margolis
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $142,560
- **Award type:** 5
- **Project period:** 2019-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969338

## Citation

> US National Institutes of Health, RePORTER application 9969338, Comparative effectiveness of spironolactone versus oral tetracycline-class antibiotics for the treatment of moderate to severe acne in women (5R34AR074733-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9969338. Licensed CC0.

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