FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial
Abstract Background Acne vulgaris has increased in women over the past 10 years; it currently affects 20–30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of syst...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-06-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04432-w |
| _version_ | 1818176735879888896 |
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| author | Alexandra Poinas Marie Lemoigne Sarah Le Naour Jean-Michel Nguyen Solène Schirr-Bonnans Valery-Pierre Riche Florence Vrignaud Laurent Machet Jean-Paul Claudel Marie-Thérèse Leccia Ewa Hainaut Nathalie Beneton Cécile Dert Aurélie Boisrobert Laurent Flet Anne Chiffoleau Stéphane Corvec Amir Khammari Brigitte Dréno |
| author_facet | Alexandra Poinas Marie Lemoigne Sarah Le Naour Jean-Michel Nguyen Solène Schirr-Bonnans Valery-Pierre Riche Florence Vrignaud Laurent Machet Jean-Paul Claudel Marie-Thérèse Leccia Ewa Hainaut Nathalie Beneton Cécile Dert Aurélie Boisrobert Laurent Flet Anne Chiffoleau Stéphane Corvec Amir Khammari Brigitte Dréno |
| author_sort | Alexandra Poinas |
| collection | DOAJ |
| description | Abstract Background Acne vulgaris has increased in women over the past 10 years; it currently affects 20–30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone’s efficacy in order to establish it as an alternative to cyclines. Methods Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. Discussion The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. Trial registration ClinicalTrials.gov: NCT03334682 . Registered on 7 November 2017. |
| first_indexed | 2024-12-11T20:20:55Z |
| format | Article |
| id | doaj.art-9afc2f4f1dc141fea96837116917d020 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T20:20:55Z |
| publishDate | 2020-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9afc2f4f1dc141fea96837116917d0202022-12-22T00:52:04ZengBMCTrials1745-62152020-06-0121111610.1186/s13063-020-04432-wFASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trialAlexandra Poinas0Marie Lemoigne1Sarah Le Naour2Jean-Michel Nguyen3Solène Schirr-Bonnans4Valery-Pierre Riche5Florence Vrignaud6Laurent Machet7Jean-Paul Claudel8Marie-Thérèse Leccia9Ewa Hainaut10Nathalie Beneton11Cécile Dert12Aurélie Boisrobert13Laurent Flet14Anne Chiffoleau15Stéphane Corvec16Amir Khammari17Brigitte Dréno18Clinical Investigation Centre CIC1413, CHU Nantes and INSERMDermatology Department, CHU Nantes, Nantes University, CRCINADermatology Department, CHU Nantes, Nantes University, CRCINADepartment of Epidemiology and Biostatistics, CHU NantesService Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes UniversityService Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes UniversityClinical Investigation Centre CIC1413, CHU Nantes and INSERMDepartment of Dermatology, CHU Tours, INSERM U1253, University of ToursPrivate PracticeDepartment of Dermatology, Allergology and Photobiology, CHU A. MichallonService de Dermatologie, Poitiers University HospitalService de Dermatologie, Le Mans HospitalService Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes UniversityClinical Investigation Centre CIC1413, CHU Nantes and INSERMDepartment of Pharmacy, CHU NantesDirection de la Recherche, Département Promotion, Cellule Vigilances, Centre Hospitalier Universitaire de NantesCHU Nantes, Service de Bactériologie-Hygiène Hospitalière, CRCINA, INSERM, U1232, Université de NantesClinical Investigation Centre CIC1413, CHU Nantes and INSERMClinical Investigation Centre CIC1413, CHU Nantes and INSERMAbstract Background Acne vulgaris has increased in women over the past 10 years; it currently affects 20–30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone’s efficacy in order to establish it as an alternative to cyclines. Methods Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. Discussion The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. Trial registration ClinicalTrials.gov: NCT03334682 . Registered on 7 November 2017.http://link.springer.com/article/10.1186/s13063-020-04432-wAcne vulgarisSpironolactoneCycline |
| spellingShingle | Alexandra Poinas Marie Lemoigne Sarah Le Naour Jean-Michel Nguyen Solène Schirr-Bonnans Valery-Pierre Riche Florence Vrignaud Laurent Machet Jean-Paul Claudel Marie-Thérèse Leccia Ewa Hainaut Nathalie Beneton Cécile Dert Aurélie Boisrobert Laurent Flet Anne Chiffoleau Stéphane Corvec Amir Khammari Brigitte Dréno FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial Trials Acne vulgaris Spironolactone Cycline |
| title | FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial |
| title_full | FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial |
| title_fullStr | FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial |
| title_full_unstemmed | FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial |
| title_short | FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial |
| title_sort | fasce the benefit of spironolactone for treating acne in women study protocol for a randomized double blind trial |
| topic | Acne vulgaris Spironolactone Cycline |
| url | http://link.springer.com/article/10.1186/s13063-020-04432-w |
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