Official Title
Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
Phase
Phase 3Lead Sponsor
Pierre FabreStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Cortico AtrophyIntervention/Treatment
rv3391 ...Study Participants
60Methodology :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
Study conduct
Two steps for each patient:
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 corticotherapy, each patient will apply RV3391A on anterior side of a forearm and the placebo on the other side (randomised) for 3 months.
Clinical exam and objective measurements will be realised.
This step will allow us to describe and compare the evolution of cutaneous atrophy's markers produced by glucocorticoïds markers between M0 and M3:
between topical and oral corticotherapy
between RV3391A and the placebo.
the second step, the cohort follow-up, leading off the end of the first step (M3 à M24) The period of the second step will depend on the progression of patient's disease and on the period of his medical follow-up. This period may lasting until the 24th month after the inclusion in the study.
The patients will not apply RV3391A and the placebo anymore. They will be followed-up in the CHU.Assessments of the cutaneous atrophy's markers produced by glucocorticoïds will be realised at M6, M12, M18 and M24 with non invasive methods (clinical scoring, imaging, extensometry) to exactly describe on a long-term period the evolution of the ACIC. The assessments on forearm having received the placebo will allow us to know natural history of skin atrophy induced by corticotherapy.
A standardized quantity of each product will be applied on the evening on anterior side of forearm. The side of application will be randomized.
placebo
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
