Cortico Atrophy Clinical Trial
Official title:
Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
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
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 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.
2. 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)