Psoriasis VulgarisPhase 2Microbiome&PsoNCT03584360
Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin
A Phase 2 study testing Betamethasone-Calcipotriene Topical in people with Psoriasis Vulgaris, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Changes in microbiome have been reported recently in psoriasis lesions compared to healthy surround skin. Preliminary data showed that systemic treatments of psoriasis induce modification of the skin microbiome that becomes similar to healthy individuals after successful treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Betamethasone-Calcipotriene Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2018to 7 Mar 2019
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age who have signed and dated an informed information and consent form,
- Subject presenting psoriasis vulgaris with lesions symmetrical in size and severity, localized on the elbows and the knees and having a severity score (PASI) <=10. The lesions must have an area of at least 4 cm²,
Who cannot join
- Psoriasis in gout, erythrodermic, exfoliative or pustular
- Subject who has received systemic treatment and has a potential action on psoriasis vulgaris
- Subject who received topical treatments or neutral emollients within 4 weeks
- Subject who received antibiotic treatment in the three months preceding the randomization visit
- Subject with known or suspected hypersensitivity to any of the constituents of the products in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Role of the Local Treatments on the Microbiome Modulation in the Psoriatic Skin. Study Monocentric, Interventional, Randomized and Single-blind
Changes in microbiome have been reported recently in psoriasis lesions compared to healthy surround skin. Preliminary data showed that systemic treatments of psoriasis induce modification of the skin microbiome that becomes similar to healthy individuals after successful treatment. The causative role of microbiome in psoriasis remains in debate. The modification of skin microbiome is suspected to be able to activate the innate immune response, namely natural killers (NKs) and immune lymphoid cells (ILCs). Three types of ILCs have been reported. ILC1 (immune lymphoid cells1) that trigger a Th1 response, ILC2 (immune lymphoid cells 2) that stimulate Th2 response and ILC3 (immune lymphoid cells 3) that induce Th17 response. Interestingly, ILC2 have been reported to be increased in atopic dermatitis while ILC3 are increased in psoriasis.
Read the detailed description
To date, there is no data on the impact of topical treatments in skin microbiome and in innate cells in psoriasis lesions. However, topical treatments remain in most cases the first and the more widely used option for mild psoriasis which represent the more prevalent form of psoriasis. Thus, it appears of great interest to assess the effect of topical psoriasis treatments on skin microbiome. To this respect, topical steroids by their action both on the inflammation but also potentially on bacteria are suspected to induce potent changes in the microbiome in treated psoriasis lesions. calcipotriol has been demonstrated to have a beneficial effect on psoriasis thanks to its action on keratinocyte differentiation and its combination with topical steroids has been shown to be superior in treating psoriasis as compared to topical steroids alone. It could be hypothesized that calcipotriol could also modify the skin microbiome.
The main objective of this study intra individual prospective study is to compare the respective effect of betamethasone associated with calcipotriol foam and placebo foam in one hand and betamethasone with calcipotriol foam to betamethasone ointment on the other hand, on skin microbiome after 4 weeks of treatments on knee or elbow lesions.
Secondary objectives are to study the impact of the treatments on ILCs (numbers and relative proportion in the 3 types) and NK in the lesions and their potential correlation with the modification of the microbiome (of note ILC can be detected and characterized in situ in skin.) To compare the relative effectiveness of the two products on targets psoriasis lesions. Tolerance and potential side effects will be also studied.
Main endpoint: quantitative and qualitative assessment of microbes on psoriasis lesions before and after the treatments compared to surrounding healthy skin control.
Secondary endpoints: Presence and types of ILCs and NK in the lesional psoriatic skin before and after treatment compared with control healthy skin assessed using immunohistofluorescence. Targeted PASI or PGA (physician Global Assessment) for the efficacy. Potential side effects.
Patients: 30 with mild psoriasis (PASI <10) affecting elbows and knees in a symmetrical manner aged of at least 18.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Betamethasone-Calcipotriene Topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone-Calcipotriene TopicalDrug
Comparison between betamethasone-calcipotriol and placebo
Betamethasone-Calcipotriene TopicalDrug
Comparison between betamethasone-calcipotriol and betamethasone
Betamethasone-Calcipotriene TopicalDrug
Comparison between betamethasone-calcipotriol and propionate de clobetasol
| Study group | Role | What they receive |
|---|---|---|
| betamethasone-calcipotriol versus placebo | Experimental | In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a placebo foam in an other area during 4 weeks. Receives: Drug: Betamethasone-Calcipotriene Topical |
| betamethasone-calcipotriol versus betamethasone | Experimental | In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a betamethasone pomade in an other area during 4 weeks. Receives: Drug: Betamethasone-Calcipotriene Topical |
| betamethasone-calcipotriol versus propionate of clobetasol | Experimental | In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a propionate of clobetasol pomade in an other area during 4 weeks. Receives: Drug: Betamethasone-Calcipotriene Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing
Measured: after 4 weeks of treatment
Qualitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing
Measured: after 4 weeks of treatment
Secondary outcomes (6)
Targetted Psoriasis Area and Severity Index for the effectiveness of the products tested.
Evaluated by PASI score (PASI= Psoriasis Area Severity Index) minimum = 0 = Absence of psoriasis maximum = 4 = very severe psoriasis
Measured: after 4 weeks of treatment
Number of ILCs and NKs on skin biopsies using immunohistochemistry
Measured: after 4 weeks of treatment
Types of ILCs and NKs on skin biopsies using immunohistochemistry
Measured: after 4 weeks of treatment
Score of overall evaluation of the investigator's treatment
Evaluated by physician global assessment (PGA) score PGA = physician global assessment minimum = 0 = healing maximum = 5 = very severe psoriasis
Measured: after 4 weeks of treatment
Evaluation of tolerance
evaluated numbers of serious adverse events
Measured: after 4 weeks of treatment
Occurrence of possible adverse effects
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start24 Sep 2018
- Primary completion24 Sep 2018
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients apply different treatment to two areas with psoriasis
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PASSERON, MD, PhD, Principal investigator, university hospital center of nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584360
- Sponsor's protocol ID
- 18-PP-03
- Acronym
- Microbiome&Pso
- Status last verified
- Apr 2019
- First submitted
- 18 Jun 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Javitz HS, Ward MM, Farber E, Nail L, Vallow SG. The direct cost of care for psoriasis and psoriatic arthritis in the United States. J Am Acad Dermatol. 2002 Jun;46(6):850-60. doi: 10.1067/mjd.2002.119669.
PubMed 12063481Schmitt JM, Ford DE. Work limitations and productivity loss are associated with health-related quality of life but not with clinical severity in patients with psoriasis. Dermatology. 2006;213(2):102-10. doi: 10.1159/000093848.
PubMed 16902286Wong VW, Martindale RG, Longaker MT, Gurtner GC. From germ theory to germ therapy: skin microbiota, chronic wounds, and probiotics. Plast Reconstr Surg. 2013 Nov;132(5):854e-861e. doi: 10.1097/PRS.0b013e3182a3c11e.
PubMed 24165637Mathieu A, Vogel TM, Simonet P. The future of skin metagenomics. Res Microbiol. 2014 Feb-Mar;165(2):69-76. doi: 10.1016/j.resmic.2013.12.002. Epub 2013 Dec 20.
PubMed 24361423Kong HH, Andersson B, Clavel T, Common JE, Jackson SA, Olson ND, Segre JA, Traidl-Hoffmann C. Performing Skin Microbiome Research: A Method to the Madness. J Invest Dermatol. 2017 Mar;137(3):561-568. doi: 10.1016/j.jid.2016.10.033. Epub 2017 Jan 4.
PubMed 28063650Kong HH, Segre JA. The Molecular Revolution in Cutaneous Biology: Investigating the Skin Microbiome. J Invest Dermatol. 2017 May;137(5):e119-e122. doi: 10.1016/j.jid.2016.07.045.
PubMed 28411842Naldi L, Svensson A, Diepgen T, Elsner P, Grob JJ, Coenraads PJ, Bavinck JN, Williams H; European Dermato-Epidemiology Network. Randomized clinical trials for psoriasis 1977-2000: the EDEN survey. J Invest Dermatol. 2003 May;120(5):738-41. doi: 10.1046/j.1523-1747.2003.12145.x.
PubMed 12713574
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Role of the Local Treatments on the Microbiome Modulation in the Psoriatic Skin. Study Monocentric, Interventional, Randomized and Single-blind
- ClinicalTrials.gov ID
- NCT03584360
- Acronym / sponsor ID
- Microbiome&Pso / 18-PP-03
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- 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.
Changes in microbiome have been reported recently in psoriasis lesions compared to healthy surround skin. Preliminary data showed that systemic treatments of psoriasis induce modification of the skin microbiome that becomes similar to healthy individuals after successful treatment. The causative role of microbiome in psoriasis remains in debate. The modification of skin microbiome is suspected to be able to activate the innate immune response, namely natural killers (NKs) and immune lymphoid cells (ILCs). Three types of ILCs have been reported. ILC1 (immune lymphoid cells1) that trigger a Th1 response, ILC2 (immune lymphoid cells 2) that stimulate Th2 response and ILC3 (immune lymphoid cells 3) that induce Th17 response. Interestingly, ILC2 have been reported to be increased in atopic dermatitis while ILC3 are increased in psoriasis.
Detailed description
To date, there is no data on the impact of topical treatments in skin microbiome and in innate cells in psoriasis lesions. However, topical treatments remain in most cases the first and the more widely used option for mild psoriasis which represent the more prevalent form of psoriasis. Thus, it appears of great interest to assess the effect of topical psoriasis treatments on skin microbiome. To this respect, topical steroids by their action both on the inflammation but also potentially on bacteria are suspected to induce potent changes in the microbiome in treated psoriasis lesions. calcipotriol has been demonstrated to have a beneficial effect on psoriasis thanks to its action on keratinocyte differentiation and its combination with topical steroids has been shown to be superior in treating psoriasis as compared to topical steroids alone. It could be hypothesized that calcipotriol could also modify the skin microbiome.
The main objective of this study intra individual prospective study is to compare the respective effect of betamethasone associated with calcipotriol foam and placebo foam in one hand and betamethasone with calcipotriol foam to betamethasone ointment on the other hand, on skin microbiome after 4 weeks of treatments on knee or elbow lesions.
Secondary objectives are to study the impact of the treatments on ILCs (numbers and relative proportion in the 3 types) and NK in the lesions and their potential correlation with the modification of the microbiome (of note ILC can be detected and characterized in situ in skin.) To compare the relative effectiveness of the two products on targets psoriasis lesions. Tolerance and potential side effects will be also studied.
Main endpoint: quantitative and qualitative assessment of microbes on psoriasis lesions before and after the treatments compared to surrounding healthy skin control.
Secondary endpoints: Presence and types of ILCs and NK in the lesional psoriatic skin before and after treatment compared with control healthy skin assessed using immunohistofluorescence. Targeted PASI or PGA (physician Global Assessment) for the efficacy. Potential side effects.
Patients: 30 with mild psoriasis (PASI <10) affecting elbows and knees in a symmetrical manner aged of at least 18.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- patients apply different treatment to two areas with psoriasis
| Arm | Type | Receives |
|---|---|---|
| betamethasone-calcipotriol versus placebo | Experimental | Drug: Betamethasone-Calcipotriene TopicalIn this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a placebo foam in an other area during 4 weeks. |
| betamethasone-calcipotriol versus betamethasone | Experimental | Drug: Betamethasone-Calcipotriene TopicalIn this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a betamethasone pomade in an other area during 4 weeks. |
| betamethasone-calcipotriol versus propionate of clobetasol | Experimental | Drug: Betamethasone-Calcipotriene TopicalIn this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a propionate of clobetasol pomade in an other area during 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age who have signed and dated an informed information and consent form,
- Subject presenting psoriasis vulgaris with lesions symmetrical in size and severity, localized on the elbows and the knees and having a severity score (PASI) <=10. The lesions must have an area of at least 4 cm²,
Key exclusion criteria (5 listed)
- Psoriasis in gout, erythrodermic, exfoliative or pustular
- Subject who has received systemic treatment and has a potential action on psoriasis vulgaris
- Subject who received topical treatments or neutral emollients within 4 weeks
- Subject who received antibiotic treatment in the three months preceding the randomization visit
- Subject with known or suspected hypersensitivity to any of the constituents of the products in the study
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 |
|---|---|---|
| Betamethasone-Calcipotriene TopicalComparison between betamethasone-calcipotriol and placebo | Drug | betamethasone-calcipotriol versus placebo |
| Betamethasone-Calcipotriene TopicalComparison between betamethasone-calcipotriol and betamethasone | Drug | betamethasone-calcipotriol versus betamethasone |
| Betamethasone-Calcipotriene TopicalComparison between betamethasone-calcipotriol and propionate de clobetasol | Drug | betamethasone-calcipotriol versus propionate of clobetasol |
Primary outcome
Quantitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing
Time frame: after 4 weeks of treatment
Qualitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing
Time frame: after 4 weeks of treatment
6 secondary outcomes
Targetted Psoriasis Area and Severity Index for the effectiveness of the products tested.
Time frame: after 4 weeks of treatment
Number of ILCs and NKs on skin biopsies using immunohistochemistry
Time frame: after 4 weeks of treatment
Types of ILCs and NKs on skin biopsies using immunohistochemistry
Time frame: after 4 weeks of treatment
Score of overall evaluation of the investigator's treatment
Time frame: after 4 weeks of treatment
Evaluation of tolerance
Time frame: after 4 weeks of treatment
Occurrence of possible adverse effects
Time frame: after 4 weeks of treatment
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 18 Apr 2019.
- Background: PubMed 12063481Javitz HS, Ward MM, Farber E, Nail L, Vallow SG. The direct cost of care for psoriasis and psoriatic arthritis in the United States. J Am Acad Dermatol. 2002 Jun;46(6):850-60. doi: 10.1067/mjd.2002.119669.
- Background: PubMed 16902286Schmitt JM, Ford DE. Work limitations and productivity loss are associated with health-related quality of life but not with clinical severity in patients with psoriasis. Dermatology. 2006;213(2):102-10. doi: 10.1159/000093848.
- Background: PubMed 24165637Wong VW, Martindale RG, Longaker MT, Gurtner GC. From germ theory to germ therapy: skin microbiota, chronic wounds, and probiotics. Plast Reconstr Surg. 2013 Nov;132(5):854e-861e. doi: 10.1097/PRS.0b013e3182a3c11e.
- Background: PubMed 24361423Mathieu A, Vogel TM, Simonet P. The future of skin metagenomics. Res Microbiol. 2014 Feb-Mar;165(2):69-76. doi: 10.1016/j.resmic.2013.12.002. Epub 2013 Dec 20.
- Background: PubMed 28063650Kong HH, Andersson B, Clavel T, Common JE, Jackson SA, Olson ND, Segre JA, Traidl-Hoffmann C. Performing Skin Microbiome Research: A Method to the Madness. J Invest Dermatol. 2017 Mar;137(3):561-568. doi: 10.1016/j.jid.2016.10.033. Epub 2017 Jan 4.
- Background: PubMed 28411842Kong HH, Segre JA. The Molecular Revolution in Cutaneous Biology: Investigating the Skin Microbiome. J Invest Dermatol. 2017 May;137(5):e119-e122. doi: 10.1016/j.jid.2016.07.045.
- Results publication: PubMed 12713574Naldi L, Svensson A, Diepgen T, Elsner P, Grob JJ, Coenraads PJ, Bavinck JN, Williams H; European Dermato-Epidemiology Network. Randomized clinical trials for psoriasis 1977-2000: the EDEN survey. J Invest Dermatol. 2003 May;120(5):738-41. doi: 10.1046/j.1523-1747.2003.12145.x.
- Individual participant dataSharing planned: No
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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.
Thierry PASSERON, MD, PhD principal investigator
university hospital center of nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamethasone-Calcipotriene Topical in people with Psoriasis Vulgaris, run by Centre Hospitalier Universitaire de Nice 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 2 inclusion and 5 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 18 Apr 2019. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing (time frame: after 4 weeks of treatment). The study lists 2 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 NCT03584360, which also lists 7 linked publications.
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 18 Apr 2019.