Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids - Full Text View

Sponsors and Collaborators:	Pierre Fabre Dermo Cosmetique CNRS_Université Toulouse 3 UMR 5165, Département de Dermatologie de l’Université de Genève (Pr Kaya) Centre Européen de Recherche sur la Peau, Pierre Fabre BIOMETRIE
Information provided by:	Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:	NCT00709579

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids

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: Placebo Comparator	Drug: Placebo placebo
RV3391A: Active Comparator	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.

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,

Département de Dermatologie de l’Université de Genève (Pr Kaya)

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

Responsible Party:	Pierre Fabre Dermo Cosmetique ( Anne-Marie SCHMITT )
Study ID Numbers:	MODULCORTICOATROPHIE, 2007-A00675-48
Study First Received:	June 30, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00709579
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Pierre Fabre Dermo Cosmetique:

Patients needing an oral corticotherapy
Patients needing a topical corticotherapy
Corticotherapy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Atrophy

ClinicalTrials.gov processed this record on January 14, 2009