Cortico AtrophyPhase 3NCT00709579
Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
A Phase 3 study testing RV3391A in people with Cortico Atrophy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cortico Atrophy
- What is being tested?
- RV3391A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Cortico Atrophy
- Being tested
- RV3391A, Placebo
- Keywords
- Patients needing an oral corticotherapy, Patients needing a topical corticotherapy, Corticotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| RV3391A | Active comparator | Not described Receives: Drug: RV3391A |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 Mhz echography : Dermal Thickness
Measured: M0 versus M3
Secondary outcomes (7)
20 Mhz echography : Dermal Thickness
Measured: M0 versus M6, M12, M18, M24
Optical Coherent Tomography : Epidermal Thickness
Measured: M0, M1, M3, M6, M12, M18, M24
Frosch Score
Measured: M0, M1, M3, M6, M12, M18, M24
Cutometry: assessment of the skin mechanical properties
Measured: M0, M1, M3, M6, M12, M18, M24
Histology: study of skin layers and assessment of collagen and other proteins.
Measured: M0, M3
Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin.
Measured: 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
Measured: M0, M3,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortico AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Paul Sabatier of Toulouse, University Hospital, Geneva, Centre Européen de Recherche sur la Peau,, Pierre Fabre BIOMETRIE
- Investigators
- Laurent Sailler, Professor, Principal investigator, Centre Hospitalier UniversitaireAnne-Marie Schmitt, Doctor, Study director, Pierre Fabre Dermo CosmetiqueCarle Paul, Professor, Study director, Centre Hospitalier Universitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709579
- Sponsor's protocol ID
- MODULCORTICOATROPHIE
- Other IDs
- 2007-A00675-48
- Status last verified
- Jul 2008
- First submitted
- 30 Jun 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids
- ClinicalTrials.gov ID
- NCT00709579
- Acronym / sponsor ID
- MODULCORTICOATROPHIE
- Conditions
- Cortico Atrophy
- Keywords
- Patients needing an oral corticotherapy, Patients needing a topical corticotherapy, Corticotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Collaborators
- University Paul Sabatier of Toulouse, University Hospital, Geneva, Centre Européen de Recherche sur la Peau,, Pierre Fabre BIOMETRIE
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| RV3391A | Active comparator | Drug: RV3391A |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients needing an oral corticotherapy:
- Patients needing a topical corticotherapy:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV3391AA standardized quantity of each product will be applied on the evening on anterior side of forearm. The side of application will be randomized. | Drug | RV3391A |
| Placeboplacebo | Drug | placebo |
Primary outcome
20 Mhz echography : Dermal Thickness
Time frame: M0 versus M3
7 secondary outcomes
20 Mhz echography : Dermal Thickness
Time frame: M0 versus M6, M12, M18, M24
Optical Coherent Tomography : Epidermal Thickness
Time frame: M0, M1, M3, M6, M12, M18, M24
Frosch Score
Time frame: M0, M1, M3, M6, M12, M18, M24
Cutometry: assessment of the skin mechanical properties
Time frame: M0, M1, M3, M6, M12, M18, M24
Histology: study of skin layers and assessment of collagen and other proteins.
Time frame: M0, M3
Immunohistology and molecular biology: assessment of CD44, HB-EGF and erbB1, cutaneous cytokines, filaggrin, corneodesmosin and involucrin.
Time frame: 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
Time frame: M0, M3,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Sailler, Professor principal investigator
Centre Hospitalier Universitaire
Anne-Marie Schmitt, Doctor study director
Pierre Fabre Dermo Cosmetique
Carle Paul, Professor study director
Centre Hospitalier Universitaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RV3391A in people with Cortico Atrophy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 Mhz echography : Dermal Thickness (time frame: M0 versus M3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2008.