NCT00709579

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 8, 2008

Status Verified

July 1, 2008

Enrollment Period

2.2 years

First QC Date

June 30, 2008

Last Update Submit

July 3, 2008

Conditions

Cortico Atrophy

Keywords

Patients needing an oral corticotherapyPatients needing a topical corticotherapyCorticotherapy

Outcome Measures

Primary Outcomes (1)

  • 20 Mhz echography : Dermal Thickness

    M0 versus M3

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

RV3391A

ACTIVE COMPARATOR
Drug: RV3391A

Interventions

RV3391ADRUG

A standardized quantity of each product will be applied on the evening on anterior side of forearm. The side of application will be randomized.

RV3391A
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hopitalier Universitaire de Toulouse

Toulouse, 31052, France

Location

Study Officials

  • Laurent Sailler, Professor

    Centre Hospitalier Universitaire

    PRINCIPAL INVESTIGATOR

  • Anne-Marie Schmitt, Doctor

    Pierre Fabre Dermo Cosmetique

    STUDY DIRECTOR

  • Carle Paul, Professor

    Centre Hospitalier Universitaire

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 8, 2008

Record last verified: 2008-07

Locations

FR(1)