Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
NCT ID: NCT01407471
Last Updated: 2015-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2011-09-30
2012-05-31
Brief Summary
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Detailed Description
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The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. Experimental results in animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing.
Study description We propose to test clinically these hypotheses for the first time on humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Clobetasol + Spironolactone
0.05% clobetasol and 5% spironolactone
Clobetasol + Spironolactone
One application 6 days a week during 4 weeks
Clobetasol + Placebo
0.05% clobetasol + inert excipient
Clobetasol + Placebo
One application 6 days a week during 4 weeks
Placebo + Spironolactone
Inert excipient + 5% spironolactone
Placebo + Spironolactone
One application 6 days a week during 7 weeks
Placebo + placebo
Inert excipient
Placebo + Placebo
One application 6 days a week during 7 weeks
Interventions
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Clobetasol + Spironolactone
One application 6 days a week during 4 weeks
Clobetasol + Placebo
One application 6 days a week during 4 weeks
Placebo + Spironolactone
One application 6 days a week during 7 weeks
Placebo + Placebo
One application 6 days a week during 7 weeks
Eligibility Criteria
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Inclusion Criteria
* Woman with effective contraception and pregnancy test negative before inclusion.
* Subject considered healthy after a detailed review (interview, clinical examination)
* Subject belonging to a social security scheme (beneficiary or have the right)
* Subject having signed a free and informed consent
* Integrity of the skin at forearms
* Subject available the next 7 weeks and able to go to CIC once a day from Monday to Friday
* Subject accepting four skin biopsies at D29
* no washing forearms during 2 hours after applications
Exclusion Criteria
* Drug-addiction (comprehensive interview with a sampling in case of doubt)
* Woman pregnant or breast-feeding
* Subject involved in another trial or in exclusion period of another protocol
* Subject has already received more than 3700 Euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches
* Subject has already participated in this protocol
* Phototypes 5 and 6
* Clinical skin atrophy
* History of severe chronic skin disease
* Problems of healing
* Treatment with oral corticosteroids, mineralocorticoids or spironolactone (Aldactone, Flumach, Practon, Spiroctan, Spironone, Aldactazine, ALDALIX, Practazin, Spiroctazine ...)
20 Years
50 Years
ALL
Yes
Sponsors
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Société de Dermatologie Française
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Eve MAUBEC, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Bichat Hospital
Paris, , France
Countries
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References
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Farman N, Maubec E, Poeggeler B, Klatte JE, Jaisser F, Paus R. The mineralocorticoid receptor as a novel player in skin biology: beyond the renal horizon? Exp Dermatol. 2010 Feb;19(2):100-7. doi: 10.1111/j.1600-0625.2009.01011.x. Epub 2009 Nov 18.
Bayo P, Sanchis A, Bravo A, Cascallana JL, Buder K, Tuckermann J, Schutz G, Perez P. Glucocorticoid receptor is required for skin barrier competence. Endocrinology. 2008 Mar;149(3):1377-88. doi: 10.1210/en.2007-0814. Epub 2007 Nov 26.
Sainte Marie Y, Toulon A, Paus R, Maubec E, Cherfa A, Grossin M, Descamps V, Clemessy M, Gasc JM, Peuchmaur M, Glick A, Farman N, Jaisser F. Targeted skin overexpression of the mineralocorticoid receptor in mice causes epidermal atrophy, premature skin barrier formation, eye abnormalities, and alopecia. Am J Pathol. 2007 Sep;171(3):846-60. doi: 10.2353/ajpath.2007.060991. Epub 2007 Aug 3.
Stojadinovic O, Lee B, Vouthounis C, Vukelic S, Pastar I, Blumenberg M, Brem H, Tomic-Canic M. Novel genomic effects of glucocorticoids in epidermal keratinocytes: inhibition of apoptosis, interferon-gamma pathway, and wound healing along with promotion of terminal differentiation. J Biol Chem. 2007 Feb 9;282(6):4021-34. doi: 10.1074/jbc.M606262200. Epub 2006 Nov 9.
Leyvraz C, Charles RP, Rubera I, Guitard M, Rotman S, Breiden B, Sandhoff K, Hummler E. The epidermal barrier function is dependent on the serine protease CAP1/Prss8. J Cell Biol. 2005 Aug 1;170(3):487-96. doi: 10.1083/jcb.200501038.
List K, Haudenschild CC, Szabo R, Chen W, Wahl SM, Swaim W, Engelholm LH, Behrendt N, Bugge TH. Matriptase/MT-SP1 is required for postnatal survival, epidermal barrier function, hair follicle development, and thymic homeostasis. Oncogene. 2002 May 23;21(23):3765-79. doi: 10.1038/sj.onc.1205502.
Mauro T, Guitard M, Behne M, Oda Y, Crumrine D, Komuves L, Rassner U, Elias PM, Hummler E. The ENaC channel is required for normal epidermal differentiation. J Invest Dermatol. 2002 Apr;118(4):589-94. doi: 10.1046/j.1523-1747.2002.01721.x.
Perez P, Page A, Bravo A, Del Rio M, Gimenez-Conti I, Budunova I, Slaga TJ, Jorcano JL. Altered skin development and impaired proliferative and inflammatory responses in transgenic mice overexpressing the glucocorticoid receptor. FASEB J. 2001 Sep;15(11):2030-2. doi: 10.1096/fj.00-0772fje. Epub 2001 Jul 24.
Brouard M, Casado M, Djelidi S, Barrandon Y, Farman N. Epithelial sodium channel in human epidermal keratinocytes: expression of its subunits and relation to sodium transport and differentiation. J Cell Sci. 1999 Oct;112 ( Pt 19):3343-52. doi: 10.1242/jcs.112.19.3343.
Roudier-Pujol C, Rochat A, Escoubet B, Eugene E, Barrandon Y, Bonvalet JP, Farman N. Differential expression of epithelial sodium channel subunit mRNAs in rat skin. J Cell Sci. 1996 Feb;109 ( Pt 2):379-85. doi: 10.1242/jcs.109.2.379.
Kenouch S, Lombes M, Delahaye F, Eugene E, Bonvalet JP, Farman N. Human skin as target for aldosterone: coexpression of mineralocorticoid receptors and 11 beta-hydroxysteroid dehydrogenase. J Clin Endocrinol Metab. 1994 Nov;79(5):1334-41. doi: 10.1210/jcem.79.5.7962326.
Messina M, Manieri C, Musso MC, Pastorino R. Oral and topical spironolactone therapies in skin androgenization. Panminerva Med. 1990 Apr-Jun;32(2):49-55.
Maubec E, Laouenan C, Deschamps L, Nguyen VT, Scheer-Senyarich I, Wackenheim-Jacobs AC, Steff M, Duhamel S, Tubiana S, Brahimi N, Leclerc-Mercier S, Crickx B, Perret C, Aractingi S, Escoubet B, Duval X, Arnaud P, Jaisser F, Mentre F, Farman N. Topical Mineralocorticoid Receptor Blockade Limits Glucocorticoid-Induced Epidermal Atrophy in Human Skin. J Invest Dermatol. 2015 Jul;135(7):1781-1789. doi: 10.1038/jid.2015.44. Epub 2015 Feb 10.
Other Identifiers
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P071011
Identifier Type: -
Identifier Source: org_study_id
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