NCT00709579UnknownPhase 3
Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
Pierre Fabre Dermo Cosmetique1 site in 1 country60 target enrollmentStarted: June 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 20 Mhz echography : Dermal Thickness
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
placebo
Placebo Comparator
Intervention: Placebo (Drug)
RV3391A
Active Comparator
Intervention: RV3391A (Drug)
Outcomes
Primary Outcomes
20 Mhz echography : Dermal Thickness
Time Frame: M0 versus M3
Secondary Outcomes
- 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,)
Investigators
Study Sites (1)
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