<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260777</url>
  </required_header>
  <id_info>
    <org_study_id>ROTIDDOFNCAIC</org_study_id>
    <nct_id>NCT03260777</nct_id>
  </id_info>
  <brief_title>Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children</brief_title>
  <official_title>Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alopecia is a common, distressing condition that is sometimes difficult to diagnose and&#xD;
      treat.&#xD;
&#xD;
      Losing hair is not usually health threatening; it can scar a young child's vulnerable&#xD;
      self-esteem by causing immense psychological and emotional stress, not only to the patient,&#xD;
      but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed&#xD;
      and treated early to overcome the resulting problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The majority of alopecia in children is presented as patchy alopecia, which is most commonly&#xD;
      diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis,&#xD;
      trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis&#xD;
      congenita (ACC) can be easily missed.&#xD;
&#xD;
      Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the&#xD;
      recognition of morphologic structures not visible by the naked eye.&#xD;
&#xD;
      Trichoscopy allows visualization of hair shafts at high magnification and performing&#xD;
      measurements, such as hair shaft thickness, without the need of removing hair for diagnostic&#xD;
      purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and&#xD;
      perifollicular epidermis.&#xD;
&#xD;
      The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a&#xD;
      fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be&#xD;
      accepted by children and their parents.&#xD;
&#xD;
      Tinea capitis and alopecia areata are considered to be the most common causes of hairless&#xD;
      patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same&#xD;
      clinical appearance of alopecia areata, so trichoscopy has recently become a useful&#xD;
      diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab&#xD;
      investigations like fungal culture or biopsy may take several weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 18, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children.</measure>
    <time_frame>2017-2018</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Focal Non-cicatricial Alopecia</condition>
  <arm_group>
    <arm_group_label>children with Alopecia Areata</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>children with tinea capitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>children with trichotillomania</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>children with tractional alopecia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trichoscopy</intervention_name>
    <description>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.</description>
    <arm_group_label>children with Alopecia Areata</arm_group_label>
    <arm_group_label>children with tinea capitis</arm_group_label>
    <arm_group_label>children with tractional alopecia</arm_group_label>
    <arm_group_label>children with trichotillomania</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 Patients with focal non-cicatricial alopecia will be recruited from the outpatient&#xD;
        clinic of Dermatology , Venereology and Andrology department at Assiut University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -age from 3-18 years of both sexes with focal non-cicatricial alopecia.(1-5 patches of&#xD;
        alopecia)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who will not consent.&#xD;
&#xD;
          2. uncooperative children.&#xD;
&#xD;
          3. patients with active secondary bacterial infection in the alopecic patch.&#xD;
&#xD;
          4. patients with any concomitant dermatological diseases.&#xD;
&#xD;
          5. history of using any topical(1 month) or systemic treatment (3 month) for tinea&#xD;
             capitis or alopecia areata prior to the study,&#xD;
&#xD;
          6. cicatricial alopecia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut Universuty</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23937326</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22405573</PMID>
  </reference>
  <reference>
    <citation>Sarifakioglu E, Yilmaz AE, Gorpelioglu C, Orun E. Prevalence of scalp disorders and hair loss in children. Cutis. 2012 Nov;90(5):225-9.</citation>
    <PMID>23270190</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21886722</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19341940</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Aya Mohamed</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260777
org study id: ROTIDDOFNCAIC
nct id: NCT03260777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
The majority of alopecia in children is presented as patchy alopecia, which is most commonly
      diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis,
      trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis
      congenita (ACC) can be easily missed.

      Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the
      recognition of morphologic structures not visible by the naked eye.

      Trichoscopy allows visualization of hair shafts at high magnification and performing
      measurements, such as hair shaft thickness, without the need of removing hair for diagnostic
      purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and
      perifollicular epidermis.

      The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a
      fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be
      accepted by children and their parents.

      Tinea capitis and alopecia areata are considered to be the most common causes of hairless
      patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same
      clinical appearance of alopecia areata, so trichoscopy has recently become a useful
      diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab
      investigations like fungal culture or biopsy may take several weeks.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children.
time frame: 2017-2018
description: 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.
arm group label: children with Alopecia Areata
arm group label: children with tinea capitis
arm group label: children with trichotillomania
arm group label: children with tractional alopecia
intervention type: Device
intervention name: Trichoscopy
description: 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.
arm group label: children with Alopecia Areata
arm group label: children with tinea capitis
arm group label: children with tractional alopecia
arm group label: children with trichotillomania
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Egypt
citation: 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: 23937326
citation: 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: 22405573
citation: 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: 23270190
citation: 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: 21886722
citation: 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: 19341940
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Aya Mohamed
investigator title: Principle Investigator
mesh term: Alopecia
mesh term: Alopecia Areata