PsoriasisNCT01538342
Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis
A study testing 3 Biopsies, 2 biopsies and biopsy in people with Psoriasis and Atopic Dermatitis, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- 3 Biopsies, 2 biopsies and biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2012to Jul 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Psoriasis arms:
- Plaque psoriasis and erythrodermic more than 10% of body surface area.
- Pustular psoriasis of at least 1% of body surface.
- Atopic dermatitis arm:Patients with atopic dermatitis has been identified and inflammatory lesions on the skin.
- Healthy arm:People not suffering from any skin disease
Who cannot join
- Systemic treatment of psoriasis for at least 4 weeks and / or local treatment for at least 2 weeks at the time of study entry.
- Patient with significant infection and / or immunocompromised.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Assistance Publique - Hôpitaux de Marseille
Marseille, 13 005
University Hospital of Nice
Nice, 06000
University Hospital of Toulouse
Toulouse, 31059
About this study
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family, develop an inflammatory syndrome with the characteristics of human psoriasis.
To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the investigators intend to develop a clinical study to analyze the expression, cleavage and activity of Lyn and the activation of caspases from skin biopsies of patients with this disease.
Read more
This study will be conducted on a cohort of patients with different forms of psoriasis (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated with chronic inflammation. Thus, the investigators will evaluate the expression and activity of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the level of caspase activation and apoptotic inflammatory.
Thus, the investigators will verify that the cleavage by caspases of Lyn is associated specifically with psoriasis, as the investigators believe, or more generally to the skin inflammation. The investigators work would then define the cleavage by caspases of Lyn as a new potential marker of human psoriasis.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- 3 Biopsies, 2 biopsies, biopsy
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 BiopsiesOther
3 biopsies: 2 lesional and 1 non-lesional
2 biopsiesOther
Also called 1 lesional and 1 non-lesional
biopsyOther
1 biopsy ok healthy skin
| Study group | Role | What they receive |
|---|---|---|
| chronic plaque psoriasis | Other | 3 biopsies: 2 lesional and 1 non-lesional Receives: Other: 3 Biopsies |
| pustular psoriasis | Other | 3 biopsies: 2 lesional and 1 non-lesional Receives: Other: 3 Biopsies |
| erythrodermic psoriasis | Other | 3 biopsies: 2 lesional and 1 non-lesional Receives: Other: 3 Biopsies |
| atopic dermatitis | Other | 2 biopsies: 1 lesional and 1 non-lesional Receives: Other: 2 biopsies |
| healthy patients | Other | 1 biopsy of healthy skin. Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleavage of Lyn
The cleavage of Lyn will be determined in the different extracts of skin of patients with western blotting using an antibody specific for Lyn recognizing the native form but also the form cleaved by caspases.
Measured: 1 day
Expression levels of Lyn
The expression levels of Lyn and its cleaved form will be quantified using the software MultiGauge. The investigators will also determine the level of activity of Lyn using an antibody directed against the active form phosphorylated. The level of expression of proteins of interest will be reported at the level of protein expression control (ERK2) whose expression does not vary depending on the samples (load control).
Measured: 1 day
Specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5
The investigators will determine the specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5 test microplate. The principle of this test is based on the use of a specific substrate of caspases coupled to a fluorochrome that fluoresces when it is released after the action of caspase-level target aspartate. The fluorescence emission, which is proportional to the amount of active caspase in the sample is then measured with a fluorometer.
Measured: 1 day
Secondary outcomes (1)
Development of a monoclonal antibodyspecific for the cleaved form of caspases by Lyn
Development of a monoclonal antibody specific for the form cleaved by caspases of Lyn. Once obtained and validated, this tool will be especially useful for immunohistological analysis of Lyn on skin sections from patients with psoriasis. Then we can also analyze which skin cells express preferentially cleaved form of Lyn.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul ORTONNE, PU-PH, Study director, Centre Hospitalier Universitaire de NiceSandrine MARCHETTI, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceMarie-Aleth RICHARD, PU-PH, Principal investigator, AP-HMCarle PAUL, PU-PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538342
- Sponsor's protocol ID
- 11-API-03
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2012
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Aira LE, Goncalves D, Bossowski JP, Rubio-Patino C, Chiche J, Paul-Bellon R, Mondragon L, Gesson M, Lecucq-Ottavi P, Obba S, Colosetti P, Luciano F, Bailly-Maitre B, Boyer L, Jacquel A, Robert G, Ricci JE, Ortonne JP, Passeron T, Lacour JP, Auberger P, Marchetti S. Caspase 1/11 Deficiency or Pharmacological Inhibition Mitigates Psoriasis-Like Phenotype in Mice. J Invest Dermatol. 2019 Jun;139(6):1306-1317. doi: 10.1016/j.jid.2018.11.031. Epub 2018 Dec 17.
PubMed 30571969
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis
- ClinicalTrials.gov ID
- NCT01538342
- Acronym / sponsor ID
- 11-API-03
- Conditions
- Psoriasis, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Feb 2012 (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.
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family, develop an inflammatory syndrome with the characteristics of human psoriasis.
To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the investigators intend to develop a clinical study to analyze the expression, cleavage and activity of Lyn and the activation of caspases from skin biopsies of patients with this disease.
This study will be conducted on a cohort of patients with different forms of psoriasis (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated with chronic inflammation. Thus, the investigators will evaluate the expression and activity of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the level of caspase activation and apoptotic inflammatory.
Thus, the investigators will verify that the cleavage by caspases of Lyn is associated specifically with psoriasis, as the investigators believe, or more generally to the skin inflammation. The investigators work would then define the cleavage by caspases of Lyn as a new potential marker of human psoriasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| chronic plaque psoriasis | Other | Other: 3 Biopsies3 biopsies: 2 lesional and 1 non-lesional |
| pustular psoriasis | Other | Other: 3 Biopsies3 biopsies: 2 lesional and 1 non-lesional |
| erythrodermic psoriasis | Other | Other: 3 Biopsies3 biopsies: 2 lesional and 1 non-lesional |
| atopic dermatitis | Other | Other: 2 biopsies2 biopsies: 1 lesional and 1 non-lesional |
| healthy patients | Other | Other: biopsy1 biopsy of healthy skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Plaque psoriasis and erythrodermic more than 10% of body surface area.
- Pustular psoriasis of at least 1% of body surface.
Key exclusion criteria (2 listed)
- Systemic treatment of psoriasis for at least 4 weeks and / or local treatment for at least 2 weeks at the time of study entry.
- Patient with significant infection and / or immunocompromised.
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 |
|---|---|---|
| 3 Biopsies3 biopsies: 2 lesional and 1 non-lesional | Other | chronic plaque psoriasis, erythrodermic psoriasis, pustular psoriasis |
| 2 biopsiesAlso: 1 lesional and 1 non-lesional | Other | atopic dermatitis |
| biopsy1 biopsy ok healthy skin | Other | healthy patients |
Primary outcome
Cleavage of Lyn
Time frame: 1 day
The cleavage of Lyn will be determined in the different extracts of skin of patients with western blotting using an antibody specific for Lyn recognizing the native form but also the form cleaved by caspases.
Expression levels of Lyn
Time frame: 1 day
The expression levels of Lyn and its cleaved form will be quantified using the software MultiGauge. The investigators will also determine the level of activity of Lyn using an antibody directed against the active form phosphorylated. The level of expression of proteins of interest will be reported at the level of protein expression control (ERK2) whose expression does not vary depending on the samples (load control).
Specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5
Time frame: 1 day
The investigators will determine the specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5 test microplate. The principle of this test is based on the use of a specific substrate of caspases coupled to a fluorochrome that fluoresces when it is released after the action of caspase-level target aspartate. The fluorescence emission, which is proportional to the amount of active caspase in the sample is then measured with a fluorometer.
1 secondary outcome
Development of a monoclonal antibodyspecific for the cleaved form of caspases by Lyn
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 30571969Aira LE, Goncalves D, Bossowski JP, Rubio-Patino C, Chiche J, Paul-Bellon R, Mondragon L, Gesson M, Lecucq-Ottavi P, Obba S, Colosetti P, Luciano F, Bailly-Maitre B, Boyer L, Jacquel A, Robert G, Ricci JE, Ortonne JP, Passeron T, Lacour JP, Auberger P, Marchetti S. Caspase 1/11 Deficiency or Pharmacological Inhibition Mitigates Psoriasis-Like Phenotype in Mice. J Invest Dermatol. 2019 Jun;139(6):1306-1317. doi: 10.1016/j.jid.2018.11.031. Epub 2018 Dec 17.
- Related InfoLink provided by the sponsor.
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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.
Jean-Paul ORTONNE, PU-PH study director
Centre Hospitalier Universitaire de Nice
Sandrine MARCHETTI, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
Marie-Aleth RICHARD, PU-PH principal investigator
AP-HM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Biopsies, 2 biopsies and biopsy in people with Psoriasis and Atopic Dermatitis, run by Centre Hospitalier Universitaire de Nice at 3 sites 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cleavage of Lyn (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538342, which also lists 1 linked publication.
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 31 Mar 2026.