Mycosis Fungoides of SkinNCT05433727
Dermoscopic Findings of Small Plaque Parapsoriasis and Patch Stage Mycosis Fungoides and Histopathological Correlation
An observational study of Mycosis Fungoides of Skin, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Dermoscopic findings of small plaque parapsoriasis and patch stage mycosis fungoides (MF),histopathological correlation of the dermoscopic findings, and using these findings to differentiate two diseases by demonstrating the difference in diagnostic success of dermatologists Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mycosis Fungoides of Skin
- What is being tested?
- videodermoscopy, lesional capillaroscopy
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 14 Jun 2022
- How long will I take part?
- 1 Day
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were applied to Istanbul Teaching and Research hospital dermatology clinic between february 2022 and june 2022 and who meet each eligibility criteria were included to the study.
Who may be able to join
- Patient who have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
- over the age of 18
- who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
- patient who have patch lesions on their body
Who cannot join
- Patient who do not have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
- under the age of 18
- who have received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
- patient who does not have patch lesions on their body
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Teaching and Research Hospital
Istanbul, Istanbul/Fatih, 34098
About this study
Official title: Dermoscopic Findings of Small Plaque Parapsoriasis and Patch Stage Mycosis Fungoides, Histopathological Correlation With the Dermoscopic Findings and Diagnostic Accuracy of Dermatologists Using Dermoscopic Findings
Dermoscopic findings of small plaque parapsoriasis and patch stage mycosis fungoides (MF),histopathological correlation of the dermoscopic findings, and using these findings to differentiate two diseases by demonstrating the difference in diagnostic success of dermatologists
Read the detailed description
Limited number of studies have been conducted on the dermoscopic findings of mycosis fungoides (MF) and small plaque parapsoriasis for the differentiation of these two diseases. Therefore, prospective studies involving a large number of patients and which can reach high magnification levels with videodermoscopy are needed to determine the criteria for discrimination. In our study, dermoscopic demonstration of vascularity will be achieved through videodermoscopy and capillaroscopy from the lesional skin, resulting in high magnification levels (x200).
In terms of histopathology and dermoscopy correlation, skin punch biopsy will be taken for diagnostic purposes. Videodermoscopy and lesional capillaroscopy will be performed to the same site of the lesion where punch biopsy will be taken. As a result patients who had the diagnosis of mycosis fungoides or parapsoriasis will be included to our study. After histopathological features are evaluated by pathologists, dermoscopic correlations will be examined for each lesion.
30 patients with clinical and histopathological diagnosis of mycosis fungoides, and 30 patients with clinical and histopathological diagnosis of small plaque parapsoriasis, who applied to the dermatology clinic of our hospital between february 2022 and june 2022 are included in the study. Patients did not use systemic treatment for 4 weeks and topical treatments in the last 2 weeks were included to the study.
Patient's demographical data, clinical data, videodermoscopy findings such as vascular structure (vascularity (shape, clustered, uniform, non-clustered) presence of scale ( diffuse or in patches or grooves, etc.), orange structural areas or specific clues will be evaluated. If vascularity is detected at x200 magnification in patients undergoing lesional capillaroscopy, characterization of vascularity (point, clustered, uniform, etc.) will be made.
After dermoscopic criteria are determined, the individuals whose dermatology education range from 1 to 15 years will be randomized and divided into two groups, and the correct diagnosis rates will be measured, with one group only clinical and the other group clinical and dermoscopy images together.
- Conditions
- Mycosis Fungoides of Skin
- Being tested
- videodermoscopy, lesional capillaroscopy
- Keywords
- mycosis fungoides, parapsoriasis, videodermoscopy
- Medical subject headings
- Mycosis Fungoides, Parapsoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videodermoscopy, lesional capillaroscopyDiagnostic test
videodermoscopy and lesional capillaroscopy will be performed under different magnification levels to the skin lesions and data will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Mycosis fungoides group | Patients who routinely have punch skin biopsy for diagnostic purposes and who were both clinically and histopathologically diagnosed with mycosis fungoides will be included. Patients who only have mycosis fungoides patch lesion on their body, over the age of 18, and who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks will be included. Demographic, clinical, videodermoscopy, capillaroscopy (lesional) and histopathological data will be recorded. Receives: Diagnostic Test: videodermoscopy, lesional capillaroscopy | |
| Parapsoriasis group | Patients who routinely have punch skin biopsy for diagnostic purposes and who were both clinically and histopathologically diagnosed with parapsoriasis will be included. Patients who only have parapsoriasis patch lesion on their body, over the age of 18, and who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks will be included. Demographic, clinical, videodermoscopy,capillaroscopy (lesional) and histopathological data will be recorded. Receives: Diagnostic Test: videodermoscopy, lesional capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between videodermoscopy/capillaroscopy findings and histopathological findings of mycosis fungoides and parapsoriasis patients
Videodermoscopy/capillaroscopy and histopathological data will be recorded and evaluated for corelation
Measured: 1 day (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start14 Feb 2022
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mycosis Fungoides of SkinStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dilara İlhan Erdil, Istanbul Training and Research Hospital
- Investigators
- Ayse Esra Koku Aksu, MD, Study chair, Istanbul Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433727
- Sponsor's protocol ID
- 11.02.2022 karar no:48
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lallas A, Apalla Z, Lefaki I, Tzellos T, Karatolias A, Sotiriou E, Lazaridou E, Ioannides D, Zalaudek I, Argenziano G. Dermoscopy of early stage mycosis fungoides. J Eur Acad Dermatol Venereol. 2013 May;27(5):617-21. doi: 10.1111/j.1468-3083.2012.04499.x. Epub 2012 Mar 9.
PubMed 22404051Xu C, Liu J, Wang T, Luo Y, Liu Y. Dermoscopic patterns of early-stage mycosis fungoides in a Chinese population. Clin Exp Dermatol. 2019 Mar;44(2):169-175. doi: 10.1111/ced.13680. Epub 2018 Jun 6.
PubMed 29876963
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermoscopic Findings of Small Plaque Parapsoriasis and Patch Stage Mycosis Fungoides, Histopathological Correlation With the Dermoscopic Findings and Diagnostic Accuracy of Dermatologists Using Dermoscopic Findings
- ClinicalTrials.gov ID
- NCT05433727
- Acronym / sponsor ID
- 11.02.2022 karar no:48
- Conditions
- Mycosis Fungoides of Skin
- Keywords
- mycosis fungoides, parapsoriasis, videodermoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 27 Jun 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.
Dermoscopic findings of small plaque parapsoriasis and patch stage mycosis fungoides (MF),histopathological correlation of the dermoscopic findings, and using these findings to differentiate two diseases by demonstrating the difference in diagnostic success of dermatologists
Detailed description
Limited number of studies have been conducted on the dermoscopic findings of mycosis fungoides (MF) and small plaque parapsoriasis for the differentiation of these two diseases. Therefore, prospective studies involving a large number of patients and which can reach high magnification levels with videodermoscopy are needed to determine the criteria for discrimination. In our study, dermoscopic demonstration of vascularity will be achieved through videodermoscopy and capillaroscopy from the lesional skin, resulting in high magnification levels (x200).
In terms of histopathology and dermoscopy correlation, skin punch biopsy will be taken for diagnostic purposes. Videodermoscopy and lesional capillaroscopy will be performed to the same site of the lesion where punch biopsy will be taken. As a result patients who had the diagnosis of mycosis fungoides or parapsoriasis will be included to our study. After histopathological features are evaluated by pathologists, dermoscopic correlations will be examined for each lesion.
30 patients with clinical and histopathological diagnosis of mycosis fungoides, and 30 patients with clinical and histopathological diagnosis of small plaque parapsoriasis, who applied to the dermatology clinic of our hospital between february 2022 and june 2022 are included in the study. Patients did not use systemic treatment for 4 weeks and topical treatments in the last 2 weeks were included to the study.
Patient's demographical data, clinical data, videodermoscopy findings such as vascular structure (vascularity (shape, clustered, uniform, non-clustered) presence of scale ( diffuse or in patches or grooves, etc.), orange structural areas or specific clues will be evaluated. If vascularity is detected at x200 magnification in patients undergoing lesional capillaroscopy, characterization of vascularity (point, clustered, uniform, etc.) will be made.
After dermoscopic criteria are determined, the individuals whose dermatology education range from 1 to 15 years will be randomized and divided into two groups, and the correct diagnosis rates will be measured, with one group only clinical and the other group clinical and dermoscopy images together.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycosis fungoides group | – | Diagnostic Test: videodermoscopy, lesional capillaroscopyPatients who routinely have punch skin biopsy for diagnostic purposes and who were both clinically and histopathologically diagnosed with mycosis fungoides will be included. Patients who only have mycosis fungoides patch lesion on their body, over the age of 18, and who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks will be included. Demographic, clinical, videodermoscopy, capillaroscopy (lesional) and histopathological data will be recorded. |
| Parapsoriasis group | – | Diagnostic Test: videodermoscopy, lesional capillaroscopyPatients who routinely have punch skin biopsy for diagnostic purposes and who were both clinically and histopathologically diagnosed with parapsoriasis will be included. Patients who only have parapsoriasis patch lesion on their body, over the age of 18, and who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks will be included. Demographic, clinical, videodermoscopy,capillaroscopy (lesional) and histopathological data will be recorded. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were applied to Istanbul Teaching and Research hospital dermatology clinic between february 2022 and june 2022 and who meet each eligibility criteria were included to the study.
Key inclusion criteria (4 listed)
- Patient who have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
- over the age of 18
- who have not received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
- patient who have patch lesions on their body
Key exclusion criteria (4 listed)
- Patient who do not have clinical/histopathological diagnosis of mycosis fungoides or parapsoriasis
- under the age of 18
- who have received topical treatment for the last 2 weeks or systemic therapy for 4 weeks.
- patient who does not have patch lesions on their body
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 |
|---|---|---|
| videodermoscopy, lesional capillaroscopyvideodermoscopy and lesional capillaroscopy will be performed under different magnification levels to the skin lesions and data will be recorded. | Diagnostic test | Mycosis fungoides group, Parapsoriasis group |
Primary outcome
Correlation between videodermoscopy/capillaroscopy findings and histopathological findings of mycosis fungoides and parapsoriasis patients
Time frame: 1 day (cross-sectional)
Videodermoscopy/capillaroscopy and histopathological data will be recorded and evaluated for corelation
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 30 Jun 2022.
- Background: PubMed 22404051Lallas A, Apalla Z, Lefaki I, Tzellos T, Karatolias A, Sotiriou E, Lazaridou E, Ioannides D, Zalaudek I, Argenziano G. Dermoscopy of early stage mycosis fungoides. J Eur Acad Dermatol Venereol. 2013 May;27(5):617-21. doi: 10.1111/j.1468-3083.2012.04499.x. Epub 2012 Mar 9.
- Background: PubMed 29876963Xu C, Liu J, Wang T, Luo Y, Liu Y. Dermoscopic patterns of early-stage mycosis fungoides in a Chinese population. Clin Exp Dermatol. 2019 Mar;44(2):169-175. doi: 10.1111/ced.13680. Epub 2018 Jun 6.
- 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.
Ayse Esra Koku Aksu, MD study chair
Istanbul Teaching and Research Hospital
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 Mycosis Fungoides of Skin, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 30 Jun 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 Turkey (Türkiye). 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?
Correlation between videodermoscopy/capillaroscopy findings and histopathological findings of mycosis fungoides and parapsoriasis patients (time frame: 1 day (cross-sectional)). 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 NCT05433727, which also lists 2 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 30 Jun 2022.