NCT00709579

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Cortico Atrophy

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	placebo

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-07-03
• Last updated: 2008-07-08

Locations

1 site across 1 country: France