- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433727
Dermoscopic Findings of Small Plaque Parapsoriasis and Patch Stage Mycosis Fungoides and Histopathological Correlation
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul/Fatih
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Istanbul, Istanbul/Fatih, Turkey, 34098
- Istanbul Teaching and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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videodermoscopy and lesional capillaroscopy will be performed under different magnification levels to the skin lesions and data will be recorded.
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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.
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videodermoscopy and lesional capillaroscopy will be performed under different magnification levels to the skin lesions and data will be recorded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between videodermoscopy/capillaroscopy findings and histopathological findings of mycosis fungoides and parapsoriasis patients
Time Frame: 1 day (cross-sectional)
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Videodermoscopy/capillaroscopy and histopathological data will be recorded and evaluated for corelation
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1 day (cross-sectional)
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Collaborators and Investigators
Investigators
- Study Chair: Ayse Esra Koku Aksu, MD, Istanbul Teaching and Research Hospital
Publications and helpful links
General 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.
- Xu 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Skin Diseases, Papulosquamous
- Lymphoma
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell
- Mycoses
- Mycosis Fungoides
- Parapsoriasis
Other Study ID Numbers
- 11.02.2022 karar no:48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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