Clinical trial NCT00709579: Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
Official title: Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cortico Atrophy
Keywords: Patients needing an oral corticotherapy
Patients needing a topical corticotherapy
Corticotherapy
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
Collaborators: name: University Paul Sabatier of Toulouse
name: University Hospital, Geneva
name: Centre Européen de Recherche sur la Peau,
name: Pierre Fabre BIOMETRIE
First posted: 2008-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 20 Mhz echography : Dermal Thickness
timeFrame: M0 versus M3
Secondary outcomes:
measure: 20 Mhz echography : Dermal Thickness
timeFrame: M0 versus M6, M12, M18, M24
measure: Optical Coherent Tomography : Epidermal Thickness
timeFrame: M0, M1, M3, M6, M12, M18, M24
measure: Frosch Score
timeFrame: M0, M1, M3, M6, M12, M18, M24
measure: Cutometry: assessment of the skin mechanical properties
timeFrame: M0, M1, M3, M6, M12, M18, M24
measure: Histology: study of skin layers and assessment of collagen and other proteins.
timeFrame: M0, M3
measure: Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin.
timeFrame: M0, M3
measure: 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
timeFrame: M0, M3,
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre Hopitalier Universitaire de Toulouse
Study officials:
affiliation: Centre Hospitalier Universitaire
name: Laurent Sailler, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Pierre Fabre Dermo Cosmetique
name: Anne-Marie Schmitt, Doctor
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire
name: Carle Paul, Professor
role: STUDY_DIRECTOR
References: