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

Pierre Fabre

Status and phase: Unknown; Phase 3

Conditions: Cortico Atrophy

Treatments: Drug: RV3391A; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00709579

2007-A00675-48

MODULCORTICOATROPHIE

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RV3391A

Active Comparator group

Treatment:

Drug: RV3391A