Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Methodology :Phase III study, single centre, double blind, versus excipient, randomised, controlateral design.

Selection of the patients :Number of subjects required 60 :

• 30 patients needing an oral corticotherapy

• 30 patients needing a topical corticotherapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Dermo Cosmetique
• Collaborators: Centre Européen de Recherche sur la Peau,; Paul Sabatier University; Pierre Fabre BIOMETRIE; University Hospital, Geneva; University Paul Sabatier of Toulouse
• Treatments: Glucocorticoids

Criteria

Inclusion Criteria:

• Patients needing an oral corticotherapy:

• aged over 50 years

• first corticotherapy over 0.5 mg/kg/day

• expectable period with a corticotherapy over 10 mg/day more than 3 months

• having signed a written informed consent form

• registered with a social security or health insurance system

• Patients needing a topical corticotherapy:

• aged over 50 years

• topical corticotherapy with a high or very high potency corticoid over 10 g/day

• expectable period with a topical corticotherapy more than 3 months

• having signed a written informed consent form

• registered with a social security or health insurance system

Exclusion Criteria:

• Oral or topical corticotherapy within the last 3 months

• Cutaneous inflammation on the anterior side of the forearm

• Medical history of psychosis induced by corticotherapy

• Medical history of allergy to RV3391A product its and excipients.

• Medical history of allergy to mineral cream Avene SPF50 excipients.

• Medical history of allergy to latex, surgical tape, chlorhexidine, lidocaine or xylocaine

• Clotting disorder or anticoagulant intake

• Healing disorder

• Women who are not post-menopausal women

• Substitutive estrogenotherapy for less than 6 months

• Impossibility to be registered in the Volunteers National Register

• Inability to comply with requirements of the clinical monitoring program,

• Inability to personally sign the informed consent form

• Is deprived of his freedom by an administrative or judicial decision; or who is under guardianship or protective custody