Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Société de Dermatologie Française
• Treatments: Clobetasol; Spironolactone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 ...)