Status:
COMPLETED
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Société de Dermatologie Française
Conditions:
Cutaneous Atrophy Due to Corticosteroids
Eligibility:
All Genders
20-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.
Detailed Description
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 resu...
Eligibility Criteria
Inclusion
- 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 Friday
- Subject accepting four skin biopsies at D29
- no washing forearms during 2 hours after applications
Exclusion
- 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 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 ...)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01407471
Start Date
September 1 2011
End Date
May 1 2012
Last Update
July 3 2015
Active Locations (1)
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1
Bichat Hospital
Paris, France, 75877