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Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis (ETDT)

Primary Purpose

Tinea Capitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dermoscopy
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tinea Capitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CHU Caen
  • CHRU Lille
  • CHU Rouen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tinea capitis

Arm Description

Outcomes

Primary Outcome Measures

The presence of several hair with at least one dermoscopic appearance specific of tinea capitis
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.

Secondary Outcome Measures

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.
Concordance of dermoscopic appearance for each of the two operators.
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.
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.
Introduction or not of a local or general presumptive treatment by the clinician while waiting for the result of the fungal culture.

Full Information

First Posted
September 14, 2015
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02550496
Brief Title
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis
Acronym
ETDT
Official Title
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis. Prospective, Multicenter Study (ETDT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 4, 2015 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Capitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tinea capitis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dermoscopy
Other Intervention Name(s)
Trichoscopy
Primary Outcome Measure Information:
Title
The presence of several hair with at least one dermoscopic appearance specific of tinea capitis
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
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
Title
Concordance of dermoscopic appearance for each of the two operators.
Description
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.
Time Frame
baseline
Title
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
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Lok, PU-PH
Organizational Affiliation
CHU Amiens, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76038
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16319467
Citation
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.
Results Reference
result
PubMed Identifier
21292346
Citation
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.
Results Reference
result
PubMed Identifier
23980908
Citation
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.
Results Reference
result
PubMed Identifier
21422348
Citation
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.
Results Reference
result
PubMed Identifier
20346297
Citation
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.
Results Reference
result
PubMed Identifier
19119131
Citation
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.
Results Reference
result

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Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis

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