Status:
UNKNOWN
Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Collaborating Sponsors:
University Paul Sabatier of Toulouse
University Hospital, Geneva
Conditions:
Cortico Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 or...
Detailed Description
Study conduct Two steps for each patient: 1. the first step lasting 3 months : assessment of changes in mechanisms involved in ACIC with the RV3391A cream (M0 à M3). At the beginning of the corticot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00709579
Start Date
June 1 2008
End Date
August 1 2010
Last Update
July 8 2008
Active Locations (1)
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1
Centre Hopitalier Universitaire de Toulouse
Toulouse, France, 31052