NCT02550496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

September 14, 2015

Last Update Submit

August 9, 2018

Conditions

Tinea Capitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (4)

  • 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.

    baseline

  • Concordance of dermoscopic appearance for each of the two operators.

    baseline

  • 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.

    baseline

  • Introduction or not of a local or general presumptive treatment by the clinician while waiting for the result of the fungal culture.

    baseline

Study Arms (1)

tinea capitis

EXPERIMENTAL
Device: Dermoscopy

Interventions

DermoscopyDEVICE
Also known as: Trichoscopy
tinea capitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with clinically diagnosed tinea capitis
  • Patient has signed informed consent

You may not qualify if:

  • Patient with kerion or tinea favosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Amiens

Amiens, Picardie, 80054, France

Location

CHU Caen

Caen, 14033, France

Location

CHRU Lille

Lille, 59037, France

Location

CHU Rouen

Rouen, 76038, France

Location

Related Publications (6)

  • 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.

    PMID: 16319467RESULT

  • 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.

    PMID: 21292346RESULT

  • 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.

    PMID: 23980908RESULT

  • 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.

    PMID: 21422348RESULT

  • 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.

    PMID: 20346297RESULT

  • 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.

    PMID: 19119131RESULT

MeSH Terms

Conditions

Tinea Capitis

Interventions

Dermoscopy

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousScalp DermatosesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intravital MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Catherine Lok, PU-PH

    CHU Amiens, Service de Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 15, 2015

Study Start

March 4, 2015

Primary Completion

January 23, 2017

Study Completion

January 23, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(4)