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 Overview

• Status: Unknown
• Conditions: Cortico Atrophy
• Intervention / Treatment: Drug: Placebo; Drug: RV3391A

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31052
    • Centre Hopitalier Universitaire de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; placebo
Active Comparator: RV3391A	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
20 Mhz echography : Dermal Thickness	M0 versus M3

Secondary Outcome Measures

Outcome Measure	Time Frame
20 Mhz echography : Dermal Thickness	M0 versus M6, M12, M18, M24
Optical Coherent Tomography : Epidermal Thickness	M0, M1, M3, M6, M12, M18, M24
Frosch Score	M0, M1, M3, M6, M12, M18, M24
Cutometry: assessment of the skin mechanical properties	M0, M1, M3, M6, M12, M18, M24
Histology: study of skin layers and assessment of collagen and other proteins.	M0, M3
Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin.	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	M0, M3,

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Collaborators: University Hospital, Geneva; University Paul Sabatier of Toulouse; Centre Européen de Recherche sur la Peau,; Pierre Fabre BIOMETRIE
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 3, 2008

Study Record Updates

• Last Update Posted (Estimate): July 8, 2008
• Last Update Submitted That Met QC Criteria: July 3, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Patients needing an oral corticotherapy; Patients needing a topical corticotherapy; Corticotherapy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: MODULCORTICOATROPHIE; 2007-A00675-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No