MelasmaNCT05698342
Tissue-resident Memory T Cells Expression in Melasma
An observational study of Melasma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Melasma
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2021to 20 Dec 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 Any age
- Women only
- Child, Adult, Older adult
Study population: female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score
Who may be able to join
- female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score
Who cannot join
- Exclusion criteria were pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exer- cise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year
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
The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites but they have not been described in melasma. This a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least 1-year duration, lesional and perilesional skin biopsies were taken for PCR and DIF. The objective is to determine the transcription factors of Trm cells in malar melasma.
Read the detailed description
Melasma is a common, acquired pigmentary disorder characterized by chronic and relapsing hypermelanosis on sun-exposed areas that causes significant emotional and psychosocial impact in patients mainly in women with Fitzpatrick III-V phototypes. The treatment of melasma and the maintenance of depigmentation represents a challenge due to its frequent recurrences.
Different pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. In pathologies such as vitiligo and psoriasis, tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites. These cells have a specific profile of transcription factors (Runx3+, Notch+, Blimp1+) and CD69 + CD103 + markers. These cells have not been described in melasma.
Objective: to determine the transcription factors of Trm cells in malar melasma. This is a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least1 year duration, and no treatment in the last 4 weeks, were included. Lesional and perilesional skin biopsies were taken for PCR and DIF. The presence of trm cells has not been described or studied in melasma where there is recurrence of the dermatosis in the same site, it is essential to understand its pathogenesis in order to address directed future therapies targeting these cells that may related to the disease.
- Conditions
- Melasma
- Keywords
- blimp-1, runx-3, transcription factors, tissue-resident memory T cells
- Medical subject headings
- Melanosis
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 |
|---|---|---|
| Melasma mMASI 7 | Female patients with melasma mMASI at least 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue-resident memory T cells
To determine the difference in the levels of transcription factors of TRM cells in lesional skin and perilesional skin of patients with melasma
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 posted26 Jan 2023
- Study start1 Jul 2021
- Primary completion30 Jul 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698342
- Sponsor's protocol ID
- 81-21
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filoni A, Mariano M, Cameli N. Melasma: How hormones can modulate skin pigmentation. J Cosmet Dermatol. 2019 Apr;18(2):458-463. doi: 10.1111/jocd.12877. Epub 2019 Feb 18.
PubMed 30779300Hernandez-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.
PubMed 18419607Rodriguez-Arambula A, Torres-Alvarez B, Cortes-Garcia D, Fuentes-Ahumada C, Castanedo-Cazares JP. CD4, IL-17, and COX-2 Are Associated With Subclinical Inflammation in Malar Melasma. Am J Dermatopathol. 2015 Oct;37(10):761-6. doi: 10.1097/DAD.0000000000000378.
PubMed 26381025Lee HC, Thng TG, Goh CL. Oral tranexamic acid (TA) in the treatment of melasma: A retrospective analysis. J Am Acad Dermatol. 2016 Aug;75(2):385-92. doi: 10.1016/j.jaad.2016.03.001. Epub 2016 May 17.
PubMed 27206758Tokura Y, Phadungsaksawasdi P, Kurihara K, Fujiyama T, Honda T. Pathophysiology of Skin Resident Memory T Cells. Front Immunol. 2021 Feb 3;11:618897. doi: 10.3389/fimmu.2020.618897. eCollection 2020.
PubMed 33633737Watanabe R, Gehad A, Yang C, Scott LL, Teague JE, Schlapbach C, Elco CP, Huang V, Matos TR, Kupper TS, Clark RA. Human skin is protected by four functionally and phenotypically discrete populations of resident and recirculating memory T cells. Sci Transl Med. 2015 Mar 18;7(279):279ra39. doi: 10.1126/scitranslmed.3010302.
PubMed 25787765Zou Y, Yuan H, Zhou S, Zhou Y, Zheng J, Zhu H, Pan M. The Pathogenic Role of CD4+ Tissue-Resident Memory T Cells Bearing T Follicular Helper-Like Phenotype in Pemphigus Lesions. J Invest Dermatol. 2021 Sep;141(9):2141-2150. doi: 10.1016/j.jid.2021.01.030. Epub 2021 Mar 16.
PubMed 33741391Fraczek 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 32443482Adachi T, Kobayashi T, Sugihara E, Yamada T, Ikuta K, Pittaluga S, Saya H, Amagai M, Nagao K. Hair follicle-derived IL-7 and IL-15 mediate skin-resident memory T cell homeostasis and lymphoma. Nat Med. 2015 Nov;21(11):1272-9. doi: 10.1038/nm.3962. Epub 2015 Oct 19.
PubMed 26479922
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue-resident Memory T Cells Expression in Melasma
- ClinicalTrials.gov ID
- NCT05698342
- Acronym / sponsor ID
- 81-21
- Conditions
- Melasma
- Keywords
- blimp-1, runx-3, transcription factors, tissue-resident memory T cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 26 Jan 2023 (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.
The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites but they have not been described in melasma. This a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least 1-year duration, lesional and perilesional skin biopsies were taken for PCR and DIF. The objective is to determine the transcription factors of Trm cells in malar melasma.
Detailed description
Melasma is a common, acquired pigmentary disorder characterized by chronic and relapsing hypermelanosis on sun-exposed areas that causes significant emotional and psychosocial impact in patients mainly in women with Fitzpatrick III-V phototypes. The treatment of melasma and the maintenance of depigmentation represents a challenge due to its frequent recurrences.
Different pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. In pathologies such as vitiligo and psoriasis, tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites. These cells have a specific profile of transcription factors (Runx3+, Notch+, Blimp1+) and CD69 + CD103 + markers. These cells have not been described in melasma.
Objective: to determine the transcription factors of Trm cells in malar melasma. This is a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least1 year duration, and no treatment in the last 4 weeks, were included. Lesional and perilesional skin biopsies were taken for PCR and DIF. The presence of trm cells has not been described or studied in melasma where there is recurrence of the dermatosis in the same site, it is essential to understand its pathogenesis in order to address directed future therapies targeting these cells that may related to the disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melasma mMASI 7 | – | –Female patients with melasma mMASI at least 7 |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score
Key inclusion criteria (1 listed)
- female patients with malar melasma, healthy volunteers 18 years of age and older, without previous treatment or photoprotection measures within the previous 4 weeks, who had at least 7 Modified Melasma Activity and Severity Index (mMASI) score
Key exclusion criteria (1 listed)
- Exclusion criteria were pregnancy or nursing, menopause, coexistence of other pigmentation conditions, heat exposure, regular exer- cise, diet restriction, consumption of food supplements or any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months, and women who had given birth within 1 year
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 determine the difference in the levels of transcription factors of TRM cells in lesional skin and perilesional skin of patients with melasma
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 26 Jan 2023.
- Results publication: PubMed 30779300Filoni A, Mariano M, Cameli N. Melasma: How hormones can modulate skin pigmentation. J Cosmet Dermatol. 2019 Apr;18(2):458-463. doi: 10.1111/jocd.12877. Epub 2019 Feb 18.
- Results publication: PubMed 18419607Hernandez-Barrera R, Torres-Alvarez B, Castanedo-Cazares JP, Oros-Ovalle C, Moncada B. Solar elastosis and presence of mast cells as key features in the pathogenesis of melasma. Clin Exp Dermatol. 2008 May;33(3):305-8. doi: 10.1111/j.1365-2230.2008.02724.x.
- Results publication: PubMed 26381025Rodriguez-Arambula A, Torres-Alvarez B, Cortes-Garcia D, Fuentes-Ahumada C, Castanedo-Cazares JP. CD4, IL-17, and COX-2 Are Associated With Subclinical Inflammation in Malar Melasma. Am J Dermatopathol. 2015 Oct;37(10):761-6. doi: 10.1097/DAD.0000000000000378.
- Results publication: PubMed 27206758Lee HC, Thng TG, Goh CL. Oral tranexamic acid (TA) in the treatment of melasma: A retrospective analysis. J Am Acad Dermatol. 2016 Aug;75(2):385-92. doi: 10.1016/j.jaad.2016.03.001. Epub 2016 May 17.
- Results publication: PubMed 33633737Tokura Y, Phadungsaksawasdi P, Kurihara K, Fujiyama T, Honda T. Pathophysiology of Skin Resident Memory T Cells. Front Immunol. 2021 Feb 3;11:618897. doi: 10.3389/fimmu.2020.618897. eCollection 2020.
- Results publication: PubMed 25787765Watanabe R, Gehad A, Yang C, Scott LL, Teague JE, Schlapbach C, Elco CP, Huang V, Matos TR, Kupper TS, Clark RA. Human skin is protected by four functionally and phenotypically discrete populations of resident and recirculating memory T cells. Sci Transl Med. 2015 Mar 18;7(279):279ra39. doi: 10.1126/scitranslmed.3010302.
- Results publication: PubMed 33741391Zou Y, Yuan H, Zhou S, Zhou Y, Zheng J, Zhu H, Pan M. The Pathogenic Role of CD4+ Tissue-Resident Memory T Cells Bearing T Follicular Helper-Like Phenotype in Pemphigus Lesions. J Invest Dermatol. 2021 Sep;141(9):2141-2150. doi: 10.1016/j.jid.2021.01.030. Epub 2021 Mar 16.
- 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 26479922Adachi T, Kobayashi T, Sugihara E, Yamada T, Ikuta K, Pittaluga S, Saya H, Amagai M, Nagao K. Hair follicle-derived IL-7 and IL-15 mediate skin-resident memory T cell homeostasis and lymphoma. Nat Med. 2015 Nov;21(11):1272-9. doi: 10.1038/nm.3962. Epub 2015 Oct 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Melasma, 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 1 inclusion and 1 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 26 Jan 2023. 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 NCT05698342, which also lists 9 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 26 Jan 2023; AzTrials last refreshed its copy on 28 Oct 2026.