Pemphigus VulgarisNCT04096222
Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients
An observational study of Pemphigus Vulgaris and Bullous Dermatoses, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
Trial summary
This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus Vulgaris, Bullous Dermatoses, Autoimmune Diseases
- How many people
- 42 participants
- Where
- 2 sitesMexico
- Study dates
- 29 Jun 2021to 28 Mar 2023
- Phase
- Observational
- 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
Study population: Subjects with the diagnosis of pemphigus who are 18 or older and who have curent skin activity and will receive treatment with corticosteroids with or without adjuvants. At the moment of enrollment subjects shoould not be pregnant, have concurrent autoimmune diseases with skin lesions (eg cutaneous lupus), cancer or infectious diseases.
Who may be able to join
- Current cutaneous activity of pemphigus
- Subjects will be treated with corticosteroids with or without adjuvants
- Accept and sign the informed consent
Who cannot join
- Pregnancy
- Concurrent autoimmune diseases with skin lesions
- Concurrent diagnosis of cancer
- Concurrent active infectious disease
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Not yet recruiting
Hospital General Dr. Manuel Gea González
Mexico City, 14080
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Luis Guillermo Llorente Peters, MD, 525554870900 ext. 2603, luisllorentepeters57@gmail.com
Alba Cicero Casarrubias, MD, 525554870900 ext. 2603, albcicero@gmail.com
About this study
This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment.
Read the detailed description
Pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. The first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). T lymphocytes are responsible for the initiation and maturation of the humoral response and the B cell activation required for the production of autoantibodies. In the last decade, the Th17 immune response has been implicated in the pathogenesis of pemphigus. Recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. This structures contain T lymphocytes, B lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. Most of the T cells in this structures are T helper CD4+ and express IL-21, and half of them produce IL-17.
In this study the investigators aim to evaluate comparatively the Th17 and T regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. The investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. The primary hypothesis is: active pemphigus vulgaris subjects will have different levels of TH17 response in comparison to inactive patients.
The investigators will use descriptive statistics, association and correlation test of hypothesis.
- Conditions
- Pemphigus Vulgaris, Bullous Dermatoses, Autoimmune Diseases
- Keywords
- pemphigus, Th17, IL-23, IL-17, autoimmune bullous disease
- Medical subject headings
- Pemphigus, Skin Diseases, Vesiculobullous, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active pemphigus vulgaris subjects | Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data | |
| Inactive pemphigus vulgaris subjects | Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data | |
| Healthy subjects | Healthy subjects will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) Demographic data will be documented, 2) biometric data, 3) A 34 ml blood sample will be taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Th17 cytokines in skin of pemphigus vulgaris subjects
The level of IL-17a, IL-21, IL-22, and IL-23 mRNA from skin biopsies at the time of enrollment and when the subject reaches 75% of PDAI improvement or after a year of follow-up (termination visit). The percentage of change in these two determinations will be calculated.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start29 Jun 2021
- Primary completion28 Mar 2023 (estimated)
- Study completion28 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Pemphigus VulgarisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Dr. Manuel Gea González
- Responsible party
- Sponsor
- Investigators
- Luis Guillermo Llorente Peters, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096222
- Sponsor's protocol ID
- 3012
- Status last verified
- Mar 2022
- First submitted
- 15 Aug 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agarwal V, Mittal SK, Misra R. Expression of multidrug resistance-1 protein correlates with disease activity rather than the refractoriness to methotrexate therapy in rheumatoid arthritis. Clin Rheumatol. 2009 Apr;28(4):427-33. doi: 10.1007/s10067-008-1071-1. Epub 2009 Jan 10.
PubMed 19137355Almugairen N, Hospital V, Bedane C, Duvert-Lehembre S, Picard D, Tronquoy AF, Houivet E, D'incan M, Joly P. Assessment of the rate of long-term complete remission off therapy in patients with pemphigus treated with different regimens including medium- and high-dose corticosteroids. J Am Acad Dermatol. 2013 Oct;69(4):583-8. doi: 10.1016/j.jaad.2013.05.016. Epub 2013 Jul 12.
PubMed 23850258Arakawa M, Dainichi T, Yasumoto S, Hashimoto T. Lesional Th17 cells in pemphigus vulgaris and pemphigus foliaceus. J Dermatol Sci. 2009 Mar;53(3):228-31. doi: 10.1016/j.jdermsci.2008.09.008. Epub 2008 Nov 5. No abstract available.
PubMed 18980832Asothai R, Anand V, Das D, Antil PS, Khandpur S, Sharma VK, Sharma A. Distinctive Treg associated CCR4-CCL22 expression profile with altered frequency of Th17/Treg cell in the immunopathogenesis of Pemphigus Vulgaris. Immunobiology. 2015 Oct;220(10):1129-35. doi: 10.1016/j.imbio.2015.06.008. Epub 2015 Jun 17.
PubMed 26093920Baron JM, Holler D, Schiffer R, Frankenberg S, Neis M, Merk HF, Jugert FK. Expression of multiple cytochrome p450 enzymes and multidrug resistance-associated transport proteins in human skin keratinocytes. J Invest Dermatol. 2001 Apr;116(4):541-8. doi: 10.1046/j.1523-1747.2001.01298.x.
PubMed 11286621Bauer B, Hartz AM, Miller DS. Tumor necrosis factor alpha and endothelin-1 increase P-glycoprotein expression and transport activity at the blood-brain barrier. Mol Pharmacol. 2007 Mar;71(3):667-75. doi: 10.1124/mol.106.029512. Epub 2006 Nov 28.
PubMed 17132686Borst P, Elferink RO. Mammalian ABC transporters in health and disease. Annu Rev Biochem. 2002;71:537-92. doi: 10.1146/annurev.biochem.71.102301.093055. Epub 2001 Nov 9.
PubMed 12045106Bystryn JC. Adjuvant therapy of pemphigus. Arch Dermatol. 1984 Jul;120(7):941-51.
PubMed 6375579Bystryn JC, Steinman NM. The adjuvant therapy of pemphigus. An update. Arch Dermatol. 1996 Feb;132(2):203-12.
PubMed 8629830Canete JD, Celis R, Yeremenko N, Sanmarti R, van Duivenvoorde L, Ramirez J, Blijdorp I, Garcia-Herrero CM, Pablos JL, Baeten DL. Ectopic lymphoid neogenesis is strongly associated with activation of the IL-23 pathway in rheumatoid synovitis. Arthritis Res Ther. 2015 Jul 9;17(1):173. doi: 10.1186/s13075-015-0688-0.
PubMed 26156866Cholera M, Chainani-Wu N. Management of Pemphigus Vulgaris. Adv Ther. 2016 Jun;33(6):910-58. doi: 10.1007/s12325-016-0343-4. Epub 2016 Jun 10.
PubMed 27287854Cordon-Cardo C, O'Brien JP, Boccia J, Casals D, Bertino JR, Melamed MR. Expression of the multidrug resistance gene product (P-glycoprotein) in human normal and tumor tissues. J Histochem Cytochem. 1990 Sep;38(9):1277-87. doi: 10.1177/38.9.1974900.
PubMed 1974900Cordon-Cardo C, O'Brien JP, Casals D, Rittman-Grauer L, Biedler JL, Melamed MR, Bertino JR. Multidrug-resistance gene (P-glycoprotein) is expressed by endothelial cells at blood-brain barrier sites. Proc Natl Acad Sci U S A. 1989 Jan;86(2):695-8. doi: 10.1073/pnas.86.2.695.
PubMed 2563168de la Fuente H, Baranda L, Hernandez MI, Torres-Alvarez B, Llorente L, Layseca E, Gonzalez-Amaro R. Lack of involvement of P-glycoprotein (P-gp) in pemphigus patients with poor response to steroid therapy. J Dermatol Sci. 2002 Apr;28(3):219-26. doi: 10.1016/s0923-1811(01)00169-4.
PubMed 11912009Murrell DF, Pena S, Joly P, Marinovic B, Hashimoto T, Diaz LA, Sinha AA, Payne AS, Daneshpazhooh M, Eming R, Jonkman MF, Mimouni D, Borradori L, Kim SC, Yamagami J, Lehman JS, Saleh MA, Culton DA, Czernik A, Zone JJ, Fivenson D, Ujiie H, Wozniak K, Akman-Karakas A, Bernard P, Korman NJ, Caux F, Drenovska K, Prost-Squarcioni C, Vassileva S, Feldman RJ, Cardones AR, Bauer J, Ioannides D, Jedlickova H, Palisson F, Patsatsi A, Uzun S, Yayli S, Zillikens D, Amagai M, Hertl M, Schmidt E, Aoki V, Grando SA, Shimizu H, Baum S, Cianchini G, Feliciani C, Iranzo P, Mascaro JM Jr, Kowalewski C, Hall R, Groves R, Harman KE, Marinkovich MP, Maverakis E, Werth VP. Diagnosis and management of pemphigus: Recommendations of an international panel of experts. J Am Acad Dermatol. 2020 Mar;82(3):575-585.e1. doi: 10.1016/j.jaad.2018.02.021. Epub 2018 Feb 10.
PubMed 29438767
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients
- ClinicalTrials.gov ID
- NCT04096222
- Acronym / sponsor ID
- 3012
- Conditions
- Pemphigus Vulgaris, Bullous Dermatoses, Autoimmune Diseases
- Keywords
- pemphigus, Th17, IL-23, IL-17, autoimmune bullous disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Hospital General Dr. Manuel Gea González
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 28 Mar 2023 (estimated)
- Study completion
- 28 Mar 2023 (estimated)
- First posted
- 19 Sep 2019 (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.
This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment.
Detailed description
Pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. The first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). T lymphocytes are responsible for the initiation and maturation of the humoral response and the B cell activation required for the production of autoantibodies. In the last decade, the Th17 immune response has been implicated in the pathogenesis of pemphigus. Recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. This structures contain T lymphocytes, B lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. Most of the T cells in this structures are T helper CD4+ and express IL-21, and half of them produce IL-17.
In this study the investigators aim to evaluate comparatively the Th17 and T regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. The investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. The primary hypothesis is: active pemphigus vulgaris subjects will have different levels of TH17 response in comparison to inactive patients.
The investigators will use descriptive statistics, association and correlation test of hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active pemphigus vulgaris subjects | – | –Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data |
| Inactive pemphigus vulgaris subjects | – | –Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data |
| Healthy subjects | – | –Healthy subjects will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) Demographic data will be documented, 2) biometric data, 3) A 34 ml blood sample will be taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with the diagnosis of pemphigus who are 18 or older and who have curent skin activity and will receive treatment with corticosteroids with or without adjuvants. At the moment of enrollment subjects shoould not be pregnant, have concurrent autoimmune diseases with skin lesions (eg cutaneous lupus), cancer or infectious diseases.
Key inclusion criteria (3 listed)
- Current cutaneous activity of pemphigus
- Subjects will be treated with corticosteroids with or without adjuvants
- Accept and sign the informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Concurrent autoimmune diseases with skin lesions
- Concurrent diagnosis of cancer
- Concurrent active infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Th17 cytokines in skin of pemphigus vulgaris subjects
Time frame: Enrollment
The level of IL-17a, IL-21, IL-22, and IL-23 mRNA from skin biopsies at the time of enrollment and when the subject reaches 75% of PDAI improvement or after a year of follow-up (termination visit). The percentage of change in these two determinations will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 19137355Agarwal V, Mittal SK, Misra R. Expression of multidrug resistance-1 protein correlates with disease activity rather than the refractoriness to methotrexate therapy in rheumatoid arthritis. Clin Rheumatol. 2009 Apr;28(4):427-33. doi: 10.1007/s10067-008-1071-1. Epub 2009 Jan 10.
- Background: PubMed 23850258Almugairen N, Hospital V, Bedane C, Duvert-Lehembre S, Picard D, Tronquoy AF, Houivet E, D'incan M, Joly P. Assessment of the rate of long-term complete remission off therapy in patients with pemphigus treated with different regimens including medium- and high-dose corticosteroids. J Am Acad Dermatol. 2013 Oct;69(4):583-8. doi: 10.1016/j.jaad.2013.05.016. Epub 2013 Jul 12.
- Background: PubMed 18980832Arakawa M, Dainichi T, Yasumoto S, Hashimoto T. Lesional Th17 cells in pemphigus vulgaris and pemphigus foliaceus. J Dermatol Sci. 2009 Mar;53(3):228-31. doi: 10.1016/j.jdermsci.2008.09.008. Epub 2008 Nov 5. No abstract available.
- Background: PubMed 26093920Asothai R, Anand V, Das D, Antil PS, Khandpur S, Sharma VK, Sharma A. Distinctive Treg associated CCR4-CCL22 expression profile with altered frequency of Th17/Treg cell in the immunopathogenesis of Pemphigus Vulgaris. Immunobiology. 2015 Oct;220(10):1129-35. doi: 10.1016/j.imbio.2015.06.008. Epub 2015 Jun 17.
- Background: PubMed 11286621Baron JM, Holler D, Schiffer R, Frankenberg S, Neis M, Merk HF, Jugert FK. Expression of multiple cytochrome p450 enzymes and multidrug resistance-associated transport proteins in human skin keratinocytes. J Invest Dermatol. 2001 Apr;116(4):541-8. doi: 10.1046/j.1523-1747.2001.01298.x.
- Background: PubMed 17132686Bauer B, Hartz AM, Miller DS. Tumor necrosis factor alpha and endothelin-1 increase P-glycoprotein expression and transport activity at the blood-brain barrier. Mol Pharmacol. 2007 Mar;71(3):667-75. doi: 10.1124/mol.106.029512. Epub 2006 Nov 28.
- Background: PubMed 12045106Borst P, Elferink RO. Mammalian ABC transporters in health and disease. Annu Rev Biochem. 2002;71:537-92. doi: 10.1146/annurev.biochem.71.102301.093055. Epub 2001 Nov 9.
- Background: PubMed 6375579Bystryn JC. Adjuvant therapy of pemphigus. Arch Dermatol. 1984 Jul;120(7):941-51.
- Background: PubMed 8629830Bystryn JC, Steinman NM. The adjuvant therapy of pemphigus. An update. Arch Dermatol. 1996 Feb;132(2):203-12.
- Background: PubMed 26156866Canete JD, Celis R, Yeremenko N, Sanmarti R, van Duivenvoorde L, Ramirez J, Blijdorp I, Garcia-Herrero CM, Pablos JL, Baeten DL. Ectopic lymphoid neogenesis is strongly associated with activation of the IL-23 pathway in rheumatoid synovitis. Arthritis Res Ther. 2015 Jul 9;17(1):173. doi: 10.1186/s13075-015-0688-0.
- Background: PubMed 27287854Cholera M, Chainani-Wu N. Management of Pemphigus Vulgaris. Adv Ther. 2016 Jun;33(6):910-58. doi: 10.1007/s12325-016-0343-4. Epub 2016 Jun 10.
- Background: PubMed 1974900Cordon-Cardo C, O'Brien JP, Boccia J, Casals D, Bertino JR, Melamed MR. Expression of the multidrug resistance gene product (P-glycoprotein) in human normal and tumor tissues. J Histochem Cytochem. 1990 Sep;38(9):1277-87. doi: 10.1177/38.9.1974900.
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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.
Luis Guillermo Llorente Peters, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus Vulgaris and Bullous Dermatoses, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.
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 3 inclusion and 4 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Guillermo Llorente Peters, MD (525554870900 ext. 2603, luisllorentepeters57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Th17 cytokines in skin of pemphigus vulgaris subjects (time frame: Enrollment). 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 NCT04096222, which also lists 70 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 10 Aug 2022.