NCT03260777

Brief Summary

Alopecia is a common, distressing condition that is sometimes difficult to diagnose and treat. Losing hair is not usually health threatening; it can scar a young child's vulnerable self-esteem by causing immense psychological and emotional stress, not only to the patient, but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed and treated early to overcome the resulting problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 18, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

August 21, 2017

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children.

    Characteristic trichoscopic findings will be searched for in each case such as (exclamation mark hairs, yellow and black dots) for alopecia areata. Flame hairs, tulip hairs, coiled hairs, hook hairs, v-sign and irregularly broken hairs for trichotillomania.Findings for tinea capitis (comma hairs, zigzag hairs, corkscrew hairs and block hairs).Coiled irregularly broken hairs and hair casts for tractional alopecia.

    2017-2018

Study Arms (4)

children with Alopecia Areata

Device: Trichoscopy

children with tinea capitis

Device: Trichoscopy

children with trichotillomania

Device: Trichoscopy

children with tractional alopecia

Device: Trichoscopy

Interventions

Trichoscopy (hair and scalp dermoscopy) is a noninvasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye Structures which may be visualized by trichoscopy include hair shafts of different types, the number of hairs in one pilosebaceous unit, hair follicle openings (dots), the peri and interfollicular areas and the vasculature.

children with Alopecia Areatachildren with tinea capitischildren with tractional alopeciachildren with trichotillomania

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

100 Patients with focal non-cicatricial alopecia will be recruited from the outpatient clinic of Dermatology , Venereology and Andrology department at Assiut University Hospital

You may qualify if:

  • age from 3-18 years of both sexes with focal non-cicatricial alopecia.(1-5 patches of alopecia)

You may not qualify if:

  • Patients who will not consent.
  • uncooperative children.
  • patients with active secondary bacterial infection in the alopecic patch.
  • patients with any concomitant dermatological diseases.
  • history of using any topical(1 month) or systemic treatment (3 month) for tinea capitis or alopecia areata prior to the study,
  • cicatricial alopecia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Universuty

Asyut, 71515, Egypt

Location

Related Publications (5)

  • Lencastre A, Tosti A. Role of trichoscopy in children's scalp and hair disorders. Pediatr Dermatol. 2013 Nov-Dec;30(6):674-82. doi: 10.1111/pde.12173. Epub 2013 Aug 13.

    PMID: 23937326BACKGROUND
  • Miteva M, Tosti A. Hair and scalp dermatoscopy. J Am Acad Dermatol. 2012 Nov;67(5):1040-8. doi: 10.1016/j.jaad.2012.02.013. Epub 2012 Mar 8.

    PMID: 22405573BACKGROUND
  • Sarifakioglu E, Yilmaz AE, Gorpelioglu C, Orun E. Prevalence of scalp disorders and hair loss in children. Cutis. 2012 Nov;90(5):225-9.

    PMID: 23270190BACKGROUND
  • Rakowska A. Trichoscopy (hair and scalp videodermoscopy) in the healthy female. Method standardization and norms for measurable parameters. J Dermatol Case Rep. 2009 Apr 5;3(1):14-9. doi: 10.3315/jdcr.2008.1021.

    PMID: 21886722BACKGROUND
  • Hillmann K, Blume-Peytavi U. Diagnosis of hair disorders. Semin Cutan Med Surg. 2009 Mar;28(1):33-8. doi: 10.1016/j.sder.2008.12.005.

    PMID: 19341940BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

November 18, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations