Cutaneous Atrophy Due to Corticosteroids Clinical Trial
Official title:
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention