Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Pierre Fabre Dermo Cosmetique.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Pierre Fabre Dermo Cosmetique
Collaborators:
CNRS_Université Toulouse 3 UMR 5165,
University Hospital, Geneva
Centre Européen de Recherche sur la Peau,
Pierre Fabre BIOMETRIE
Information provided by:
Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:
NCT00709579
First received: June 30, 2008
Last updated: July 3, 2008
Last verified: July 2008
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Cortico Atrophy |
Drug: RV3391A Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids |
Resource links provided by NLM:
Further study details as provided by Pierre Fabre Dermo Cosmetique:
Primary Outcome Measures:
- 20 Mhz echography : Dermal Thickness [ Time Frame: M0 versus M3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 20 Mhz echography : Dermal Thickness [ Time Frame: M0 versus M6, M12, M18, M24 ] [ Designated as safety issue: No ]
- Optical Coherent Tomography : Epidermal Thickness [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ] [ Designated as safety issue: No ]
- Frosch Score [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ] [ Designated as safety issue: No ]
- Cutometry: assessment of the skin mechanical properties [ Time Frame: M0, M1, M3, M6, M12, M18, M24 ] [ Designated as safety issue: No ]
- Histology: study of skin layers and assessment of collagen and other proteins. [ Time Frame: M0, M3 ] [ Designated as safety issue: No ]
- Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin. [ Time Frame: M0, M3 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: M0, M3, ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
Other Name: RV3391A
|
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.
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709579
Locations
| France | |
| Centre Hopitalier Universitaire de Toulouse | |
| Toulouse, France, 31052 | |
Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
CNRS_Université Toulouse 3 UMR 5165,
University Hospital, Geneva
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 |
More Information
No publications provided
| Responsible Party: | Anne-Marie SCHMITT, Pierre Fabre Dermo Cosmetique |
| ClinicalTrials.gov Identifier: | NCT00709579 History of Changes |
| Other Study ID Numbers: | MODULCORTICOATROPHIE, 2007-A00675-48 |
| Study First Received: | June 30, 2008 |
| Last Updated: | July 3, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Pierre Fabre Dermo Cosmetique:
|
Patients needing an oral corticotherapy Patients needing a topical corticotherapy Corticotherapy |
Additional relevant MeSH terms:
|
Atrophy Pathological Conditions, Anatomical Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013