VitiligoNCT05506995
Tissue-resident Memory T Cells Expression Among the Repigmentation Patterns Induced by NB-UVB Phototherapy in Vitiligo
An observational study of Vitiligo, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
Vitiligo is the most commonly acquired depigmentation disorder characterized by selective destruction of melanocytes resulting in well-circumscribed achromic macules. Tissue-resident memory T cells (TRM) are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, produce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2021to 3 Aug 2022
- 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: Patients with clinical diagnosis of vitiligo vulgaris with more than 10 percent of the total body surface affected.
Who may be able to join
- 18 years of age or older
- Symmetric vitiligo
- Affected body surface greater than 10%
- Patients with follicular, marginal and diffuse repigmenting patterns
- No previous topical or systemic treatment in the previous 2 and 3 months, respectively
- Signed informed consent
Who cannot join
- Concomitant treatment or systemic diseases
- Pregnancy
- Drugs intake
- Mental disorders
- Acral, universal or segmental vitiligo
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78290
About this study
Vitiligo is the most commonly acquired depigmentation disorder characterized by selective destruction of melanocytes resulting in well-circumscribed achromic macules. Tissue-resident memory T cells (TRM) are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, produce cytokines, and may be implicated in relapses. NB-UVB Phototherapy induces repigmentation in certain patterns. The aim of this study was to determine the levels of TRM cells on vitiligo lesions, and after phototherapy by repigmentation pattern.
Read the detailed description
Vitiligo is the most commonly acquired depigmentation disorder characterized by the selective destruction of melanocytes. Its etiology is not yet fully understood, but the most accepted hypotheses are genetic predisposition, environmental factors, oxidative stress and immune response. In relation with the latter, the damage-associated molecular patterns activate TRM cells and induce interferon-gamma that release CXCL9/10, recruiting cytotoxic CD8+ that ultimately destroys melanocytes. Furthermore, the lesions recur 40% in the first year and in the same site, suggesting local autoimmune response by TRM cells.
The TRM cells are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, and produce cytokines. TRM cells express the CD69+CD103+ surface markers. Moreover, TRM cells express specific transcription factors like Hobbit, Blimp1, Runx3 and Notch1, which regulate their differentiation and survival.
Interleukin (IL)-15 stimulates Hobbit, which drives TRM cells long-term maintenance by blocking CCR7-S1PR1 and promoting the expression of CD103+. Blimp1 is essential for the differentiation of TRM cells, as it inhibits the differentiation of naive T cells into circulating-memory T cells, and regulates the effector function by stimulating granzyme B and promoting the expression of CD69+. Runx3 is essential for TRM cells long-term maintenance by promoting CD103+, which can also induce Blimp1 and Hobbit. Notch1 is essential for the maintenance of CD103+, facilitating the TRM-epithelium linking. Both TRM cells and central-memory T cells have been found in vitiligo lesions, and the CD69+CD103+ TRM cells are increased in vitiligo skin.
NB-UVB phototherapy is the first line treatment for vitiligo involving more than 10 percent of the body surface area, with an average response rate of 67%. It promotes repigmentation by differentiation and migration of perilesional melanocytes, tyrosinase increase and inhibition of effector and memory T cells. NB-UVB promotes different patterns of repigmentation such as follicular, marginal, and diffuse. The NB-UVB exposure causes a decrease in the transforming factor beta that maintain the expression of CD103+, but there is no data about the CD69+ modification, suggesting a possible effect on TRM cells.
Vitiligo relapses tend to be at the same site of previous lesions, suggesting local autoimmunity by the TRM cells that could be modified by UVB-NB phototherapy. Phototherapy can inhibit effector and memory-T cells; however its effect on TRM cells in vitiligo and their modification is unknown. The purpose of this study was to determine the levels of TRM cells on vitiligo lesions, and following NB-UVB phototherapy by repigmentation pattern.
- Conditions
- Vitiligo
- Keywords
- vitiligo, Ultraviolet Therapy, Pigmentation, Tissue-resident memory T cells, Hobbit, Blimp1, Runx3, Notch1
- Medical subject headings
- Vitiligo, Bicuspid Aortic Valve Disease
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 |
|---|---|---|
| Vitiligo vulgaris | A serial of vitiligo patients under treatment with UVB-NB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue-resident memory T cells
To quantify the expression of Tissue-resident memory T cells before and after phototherapy
Measured: Up to 1 year
Secondary outcomes (3)
Tissue-resident memory T cells among the repigmentation patterns
To quantify the expression of Tissue-resident memory T cells among the repigmentation patterns induced by NB-UVB phototherapy
Measured: Up to 1 year
Arrangment of the Tissue-resident memory T cells among the repigmentation patterns
To show and quantify the fluorescence intensity of the CD69+CD103+ TRM cells among the repigmentation patterns induced by NB-UVB phototherapy
Measured: Up to 1 year
TRM transcriptional factors profile
To quantify the TRM transcriptional factors expression in lesional skin and between the repigmentation patterns.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Aug 2021
- Primary completion24 Jul 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Juan P Castanedo-Cazares, MD, Principal investigator, Universidad Autonoma de San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506995
- Sponsor's protocol ID
- 63-21
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bae JM, Jung HM, Hong BY, Lee JH, Choi WJ, Lee JH, Kim GM. Phototherapy for Vitiligo: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jul 1;153(7):666-674. doi: 10.1001/jamadermatol.2017.0002.
PubMed 28355423Fraczek A, Owczarczyk-Saczonek A, Placek W. The Role of TRM Cells in the Pathogenesis of Vitiligo-A Review of the Current State-Of-The-Art. Int J Mol Sci. 2020 May 18;21(10):3552. doi: 10.3390/ijms21103552.
PubMed 32443482Riding RL, Harris JE. The Role of Memory CD8+ T Cells in Vitiligo. J Immunol. 2019 Jul 1;203(1):11-19. doi: 10.4049/jimmunol.1900027.
PubMed 31209143Richmond JM, Strassner JP, Rashighi M, Agarwal P, Garg M, Essien KI, Pell LS, Harris JE. Resident Memory and Recirculating Memory T Cells Cooperate to Maintain Disease in a Mouse Model of Vitiligo. J Invest Dermatol. 2019 Apr;139(4):769-778. doi: 10.1016/j.jid.2018.10.032. Epub 2018 Nov 10.
PubMed 30423329Behr FM, Chuwonpad A, Stark R, van Gisbergen KPJM. Armed and Ready: Transcriptional Regulation of Tissue-Resident Memory CD8 T Cells. Front Immunol. 2018 Jul 30;9:1770. doi: 10.3389/fimmu.2018.01770. eCollection 2018.
PubMed 30131803Mackay LK, Minnich M, Kragten NA, Liao Y, Nota B, Seillet C, Zaid A, Man K, Preston S, Freestone D, Braun A, Wynne-Jones E, Behr FM, Stark R, Pellicci DG, Godfrey DI, Belz GT, Pellegrini M, Gebhardt T, Busslinger M, Shi W, Carbone FR, van Lier RA, Kallies A, van Gisbergen KP. Hobit and Blimp1 instruct a universal transcriptional program of tissue residency in lymphocytes. Science. 2016 Apr 22;352(6284):459-63. doi: 10.1126/science.aad2035.
PubMed 27102484Zubair R, Hamzavi IH. Phototherapy for Vitiligo. Dermatol Clin. 2020 Jan;38(1):55-62. doi: 10.1016/j.det.2019.08.005. Epub 2019 Oct 18.
PubMed 31753192Castanedo-Cazares JP, Cortes-Garcia JD, Fuentes-Ahumada C, Martinez-Rosales K, Torres-Alvarez B. Repigmentation patterns induced by NB-UVB and their relationship with melanocytic migration and proliferation in vitiligo. Photodermatol Photoimmunol Photomed. 2016 Sep;32(5-6):269-275. doi: 10.1111/phpp.12275. Epub 2016 Oct 5.
PubMed 27627998Patra V, Laoubi L, Nicolas JF, Vocanson M, Wolf P. A Perspective on the Interplay of Ultraviolet-Radiation, Skin Microbiome and Skin Resident Memory TCRalphabeta+ Cells. Front Med (Lausanne). 2018 May 30;5:166. doi: 10.3389/fmed.2018.00166. eCollection 2018.
PubMed 29900173Azzolino V, Zapata L Jr, Garg M, Gjoni M, Riding RL, Strassner JP, Richmond JM, Harris JE. Jak Inhibitors Reverse Vitiligo in Mice but Do Not Deplete Skin Resident Memory T Cells. J Invest Dermatol. 2021 Jan;141(1):182-184.e1. doi: 10.1016/j.jid.2020.04.027. Epub 2020 May 25. No abstract available.
PubMed 32464150
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue-resident Memory T Cells Expression Among the Repigmentation Patterns Induced by NB-UVB Phototherapy in Vitiligo
- ClinicalTrials.gov ID
- NCT05506995
- Acronym / sponsor ID
- 63-21
- Conditions
- Vitiligo
- Keywords
- vitiligo, Ultraviolet Therapy, Pigmentation, Tissue-resident memory T cells, Hobbit, Blimp1, Runx3, Notch1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 18 Aug 2022 (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.
Vitiligo is the most commonly acquired depigmentation disorder characterized by selective destruction of melanocytes resulting in well-circumscribed achromic macules. Tissue-resident memory T cells (TRM) are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, produce cytokines, and may be implicated in relapses. NB-UVB Phototherapy induces repigmentation in certain patterns. The aim of this study was to determine the levels of TRM cells on vitiligo lesions, and after phototherapy by repigmentation pattern.
Detailed description
Vitiligo is the most commonly acquired depigmentation disorder characterized by the selective destruction of melanocytes. Its etiology is not yet fully understood, but the most accepted hypotheses are genetic predisposition, environmental factors, oxidative stress and immune response. In relation with the latter, the damage-associated molecular patterns activate TRM cells and induce interferon-gamma that release CXCL9/10, recruiting cytotoxic CD8+ that ultimately destroys melanocytes. Furthermore, the lesions recur 40% in the first year and in the same site, suggesting local autoimmune response by TRM cells.
The TRM cells are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, and produce cytokines. TRM cells express the CD69+CD103+ surface markers. Moreover, TRM cells express specific transcription factors like Hobbit, Blimp1, Runx3 and Notch1, which regulate their differentiation and survival.
Interleukin (IL)-15 stimulates Hobbit, which drives TRM cells long-term maintenance by blocking CCR7-S1PR1 and promoting the expression of CD103+. Blimp1 is essential for the differentiation of TRM cells, as it inhibits the differentiation of naive T cells into circulating-memory T cells, and regulates the effector function by stimulating granzyme B and promoting the expression of CD69+. Runx3 is essential for TRM cells long-term maintenance by promoting CD103+, which can also induce Blimp1 and Hobbit. Notch1 is essential for the maintenance of CD103+, facilitating the TRM-epithelium linking. Both TRM cells and central-memory T cells have been found in vitiligo lesions, and the CD69+CD103+ TRM cells are increased in vitiligo skin.
NB-UVB phototherapy is the first line treatment for vitiligo involving more than 10 percent of the body surface area, with an average response rate of 67%. It promotes repigmentation by differentiation and migration of perilesional melanocytes, tyrosinase increase and inhibition of effector and memory T cells. NB-UVB promotes different patterns of repigmentation such as follicular, marginal, and diffuse. The NB-UVB exposure causes a decrease in the transforming factor beta that maintain the expression of CD103+, but there is no data about the CD69+ modification, suggesting a possible effect on TRM cells.
Vitiligo relapses tend to be at the same site of previous lesions, suggesting local autoimmunity by the TRM cells that could be modified by UVB-NB phototherapy. Phototherapy can inhibit effector and memory-T cells; however its effect on TRM cells in vitiligo and their modification is unknown. The purpose of this study was to determine the levels of TRM cells on vitiligo lesions, and following NB-UVB phototherapy by repigmentation pattern.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitiligo vulgaris | – | –A serial of vitiligo patients under treatment with UVB-NB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of vitiligo vulgaris with more than 10 percent of the total body surface affected.
Key inclusion criteria (6 listed)
- 18 years of age or older
- Symmetric vitiligo
- Affected body surface greater than 10%
- Patients with follicular, marginal and diffuse repigmenting patterns
- No previous topical or systemic treatment in the previous 2 and 3 months, respectively
Key exclusion criteria (5 listed)
- Concomitant treatment or systemic diseases
- Pregnancy
- Drugs intake
- Mental disorders
- Acral, universal or segmental vitiligo
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
Tissue-resident memory T cells
Time frame: Up to 1 year
To quantify the expression of Tissue-resident memory T cells before and after phototherapy
3 secondary outcomes
Tissue-resident memory T cells among the repigmentation patterns
Time frame: Up to 1 year
Arrangment of the Tissue-resident memory T cells among the repigmentation patterns
Time frame: Up to 1 year
TRM transcriptional factors profile
Time frame: Up to 1 year
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 Aug 2022.
- Results publication: PubMed 28355423Bae JM, Jung HM, Hong BY, Lee JH, Choi WJ, Lee JH, Kim GM. Phototherapy for Vitiligo: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jul 1;153(7):666-674. doi: 10.1001/jamadermatol.2017.0002.
- Results publication: PubMed 32443482Fraczek A, Owczarczyk-Saczonek A, Placek W. The Role of TRM Cells in the Pathogenesis of Vitiligo-A Review of the Current State-Of-The-Art. Int J Mol Sci. 2020 May 18;21(10):3552. doi: 10.3390/ijms21103552.
- Results publication: PubMed 31209143Riding RL, Harris JE. The Role of Memory CD8+ T Cells in Vitiligo. J Immunol. 2019 Jul 1;203(1):11-19. doi: 10.4049/jimmunol.1900027.
- Results publication: PubMed 30423329Richmond JM, Strassner JP, Rashighi M, Agarwal P, Garg M, Essien KI, Pell LS, Harris JE. Resident Memory and Recirculating Memory T Cells Cooperate to Maintain Disease in a Mouse Model of Vitiligo. J Invest Dermatol. 2019 Apr;139(4):769-778. doi: 10.1016/j.jid.2018.10.032. Epub 2018 Nov 10.
- Results publication: PubMed 30131803Behr FM, Chuwonpad A, Stark R, van Gisbergen KPJM. Armed and Ready: Transcriptional Regulation of Tissue-Resident Memory CD8 T Cells. Front Immunol. 2018 Jul 30;9:1770. doi: 10.3389/fimmu.2018.01770. eCollection 2018.
- Results publication: PubMed 27102484Mackay LK, Minnich M, Kragten NA, Liao Y, Nota B, Seillet C, Zaid A, Man K, Preston S, Freestone D, Braun A, Wynne-Jones E, Behr FM, Stark R, Pellicci DG, Godfrey DI, Belz GT, Pellegrini M, Gebhardt T, Busslinger M, Shi W, Carbone FR, van Lier RA, Kallies A, van Gisbergen KP. Hobit and Blimp1 instruct a universal transcriptional program of tissue residency in lymphocytes. Science. 2016 Apr 22;352(6284):459-63. doi: 10.1126/science.aad2035.
- Results publication: PubMed 31753192Zubair R, Hamzavi IH. Phototherapy for Vitiligo. Dermatol Clin. 2020 Jan;38(1):55-62. doi: 10.1016/j.det.2019.08.005. Epub 2019 Oct 18.
- Results publication: PubMed 27627998Castanedo-Cazares JP, Cortes-Garcia JD, Fuentes-Ahumada C, Martinez-Rosales K, Torres-Alvarez B. Repigmentation patterns induced by NB-UVB and their relationship with melanocytic migration and proliferation in vitiligo. Photodermatol Photoimmunol Photomed. 2016 Sep;32(5-6):269-275. doi: 10.1111/phpp.12275. Epub 2016 Oct 5.
- Results publication: PubMed 29900173Patra V, Laoubi L, Nicolas JF, Vocanson M, Wolf P. A Perspective on the Interplay of Ultraviolet-Radiation, Skin Microbiome and Skin Resident Memory TCRalphabeta+ Cells. Front Med (Lausanne). 2018 May 30;5:166. doi: 10.3389/fmed.2018.00166. eCollection 2018.
- Results publication: PubMed 32464150Azzolino V, Zapata L Jr, Garg M, Gjoni M, Riding RL, Strassner JP, Richmond JM, Harris JE. Jak Inhibitors Reverse Vitiligo in Mice but Do Not Deplete Skin Resident Memory T Cells. J Invest Dermatol. 2021 Jan;141(1):182-184.e1. doi: 10.1016/j.jid.2020.04.027. Epub 2020 May 25. No abstract available.
- 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.
Juan P Castanedo-Cazares, MD principal investigator
Universidad Autonoma de San Luis Potosi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Universidad Autonoma de San Luis Potosí at 1 site 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 6 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 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 1 site 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?
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?
Tissue-resident memory T cells (time frame: Up to 1 year). 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 NCT05506995, which also lists 10 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 Aug 2022.