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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids|
- 20 Mhz echography : Dermal Thickness [ Time Frame: M0 versus M3 ]
- 20 Mhz echography : Dermal Thickness [ Time Frame: M0 versus M6, M12, M18, M24 ]
- Optical Coherent Tomography : Epidermal Thickness [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ]
- Frosch Score [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ]
- Cutometry: assessment of the skin mechanical properties [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ]
- Histology: study of skin layers and assessment of collagen and other proteins. [ Time Frame: M0, M3 ]
- Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin. [ Time Frame: M0, M3 ]
- Peeling with an adhesive tape: sample of superficial epidermis layers and assessment by biochemical and immunodetection methods of anti-desmoglein, anti-kallikrein 7 and anti-corneodesmosin antibodies [ Time Frame: M0, M3, ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||
|Active Comparator: RV3391A||
A standardized quantity of each product will be applied on the evening on anterior side of forearm. The side of application will be randomized.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709579
|Centre Hopitalier Universitaire de Toulouse|
|Toulouse, France, 31052|
|Principal Investigator:||Laurent Sailler, Professor||Centre Hospitalier Universitaire|
|Study Director:||Anne-Marie Schmitt, Doctor||Pierre Fabre Dermo Cosmetique|
|Study Director:||Carle Paul, Professor||Centre Hospitalier Universitaire|