- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550496
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis (ETDT)
August 9, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis. Prospective, Multicenter Study (ETDT)
Waiting for a proof by mycological culture is usually necessary before starting a systemic antifungal therapy.
It therefore seems to us interesting to evaluate the benefit of using dermoscopy in clinical diagnosis of Tinea Capitis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Caen, France, 14033
- CHU Caen
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Lille, France, 59037
- CHRU Lille
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Rouen, France, 76038
- CHU Rouen
-
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Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients with clinically diagnosed tinea capitis
- Patient has signed informed consent
Exclusion Criteria:
- Patient with kerion or tinea favosa
- Antifungal treatment within 15 days prior to inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: tinea capitis
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The presence of several hair with at least one dermoscopic appearance specific of tinea capitis
Time Frame: baseline
|
The presence of several hair with at least one dermoscopic appearance Specific of tinea capitis ( corkscrew hair , comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) correlating with The growth of a dermatophyte in the fungal culture.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermoscopic appearance (corkscrew hair, comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) according to microscopic pathogenic species.
Time Frame: baseline
|
baseline
|
|
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Concordance of dermoscopic appearance for each of the two operators.
Time Frame: baseline
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Concordance between dermoscopic interpretation (corkscrew hair, comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) of the dermatologist during the initial consultation and dermoscopic interpretation on the photographs by a blinded trained practitioner.
|
baseline
|
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Presence of a green fluorescence or not under the light of a Wood's lamp by comparing it with the result of the fungal culture.
Time Frame: baseline
|
baseline
|
|
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Introduction or not of a local or general presumptive treatment by the clinician while waiting for the result of the fungal culture.
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Catherine Lok, PU-PH, CHU Amiens, Service de Dermatologie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zalaudek I, Argenziano G, Di Stefani A, Ferrara G, Marghoob AA, Hofmann-Wellenhof R, Soyer HP, Braun R, Kerl H. Dermoscopy in general dermatology. Dermatology. 2006;212(1):7-18. doi: 10.1159/000089015.
- Micali G, Lacarrubba F, Massimino D, Schwartz RA. Dermatoscopy: alternative uses in daily clinical practice. J Am Acad Dermatol. 2011 Jun;64(6):1135-46. doi: 10.1016/j.jaad.2010.03.010. Epub 2011 Feb 3.
- Ekiz O, Sen BB, Rifaioglu EN, Balta I. Trichoscopy in paediatric patients with tinea capitis: a useful method to differentiate from alopecia areata. J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1255-8. doi: 10.1111/jdv.12246. Epub 2013 Aug 24.
- Hughes R, Chiaverini C, Bahadoran P, Lacour JP. Corkscrew hair: a new dermoscopic sign for diagnosis of tinea capitis in black children. Arch Dermatol. 2011 Mar;147(3):355-6. doi: 10.1001/archdermatol.2011.31. No abstract available.
- Sandoval AB, Ortiz JA, Rodriguez JM, Vargas AG, Quintero DG. [Dermoscopic pattern in tinea capitis]. Rev Iberoam Micol. 2010 Sep 30;27(3):151-2. doi: 10.1016/j.riam.2010.02.003. Epub 2010 Mar 24. No abstract available. Spanish.
- Slowinska M, Rudnicka L, Schwartz RA, Kowalska-Oledzka E, Rakowska A, Sicinska J, Lukomska M, Olszewska M, Szymanska E. Comma hairs: a dermatoscopic marker for tinea capitis: a rapid diagnostic method. J Am Acad Dermatol. 2008 Nov;59(5 Suppl):S77-9. doi: 10.1016/j.jaad.2008.07.009.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2015
Primary Completion (Actual)
January 23, 2017
Study Completion (Actual)
January 23, 2017
Study Registration Dates
First Submitted
September 14, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 10, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2014_843_0019
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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