Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous Atrophy Due to Corticosteroids
Intervention: Clobetasol + Spironolactone (Drug); Clobetasol + Placebo (Drug); Placebo + Spironolactone (Drug); Placebo + Placebo (Drug)
Phase: Phase 2
Sponsored by: Assistance Publique - Hôpitaux de Paris
Official(s) and/or principal investigator(s):
Eve MAUBEC, MD, Principal Investigator, Affiliation: Assistance Publique - HĂ´pitaux de Paris
The purpose of this study is to determine whether spironolactone could significantly reduce
cutaneous atrophy due to corticosteroids.
Official title: Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: histological measure of epidermal thickness
delay of healing after skin biopsies performed on day 29
Dermis thickness evaluated by ultrasound
Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry
skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent
topical glucocorticoids which are the treatment of choice for many inflammatory skin
diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible
striae, telangiectasia and secondary infections. Up to now, no treatments can prevent
efficiently skin atrophy.
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
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.
Minimum age: 20 Years.
Maximum age: 50 Years.
- Healthy volunteers of both sex, aged between 20 and 50 years
- 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
- Subject accepting four skin biopsies at D29
- no washing forearms during 2 hours after applications
- Chronic Alcoholism
- 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
- 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
Locations and Contacts
Bichat Hospital, Paris 75877, France
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Starting date: September 2011
Last updated: July 2, 2015