NCT03155958

Brief Summary

Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss. Several etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . A T cell-mediated autoimmune mechanism in genetically vulnerable individuals is the most acceptable etiology. Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss in any hair bearing area with no remarkable gender preference. Although AA may occur at any age, incidence is high among younger age groups. In fact, it is the most common form of alopecia seen in children. Various clinical patterns of alopecia have been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis (complete loss of scalp hair), and alopecia universalis (complete loss of body hair). National Alopecia Areata Foundation has devised "Severity of Alopecia Tool Score" (SALT score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT score is the sum of percentage of hair loss in the above mentioned areas.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Status
unknown

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

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 15, 2017

Last Update Submit

May 15, 2017

Conditions

Hair Loss

Outcome Measures

Primary Outcomes (1)

  • the number of patient with occular affection in alopecia areata

    percentage

    2 years

Secondary Outcomes (1)

  • correlate dermoscopic finding with disease severity and ocular finding

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.

You may qualify if:

  • patients of alopecia areata will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.

You may not qualify if:

  • Patients with documented eye disease.
  • Patients with any systemic illness.
  • Patients who received any systemic treatment with possible ocular implications in the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.

    PMID: 10727299BACKGROUND

  • Esmer O, Karadag R, Cakici O, Bilgili SG, Demircan YT, Bayramlar H, Karadag AS. Ocular findings in patients with alopecia areata. Int J Dermatol. 2016 Jul;55(7):814-8. doi: 10.1111/ijd.13114. Epub 2016 Apr 7.

    PMID: 27061214BACKGROUND

  • Ergin C, Acar M, Kaya Akis H, Gonul M, Gurdal C. Ocular findings in alopecia areata. Int J Dermatol. 2015 Nov;54(11):1315-8. doi: 10.1111/ijd.12897. Epub 2015 Jul 3.

    PMID: 26147700BACKGROUND

  • Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.

    PMID: 3549809BACKGROUND

  • Pandhi D, Singal A, Gupta R, Das G. Ocular alterations in patients of alopecia areata. J Dermatol. 2009 May;36(5):262-8. doi: 10.1111/j.1346-8138.2009.00636.x.

    PMID: 19382996BACKGROUND

  • Recupero SM, Abdolrahimzadeh S, De Dominicis M, Mollo R, Carboni I, Rota L, Calvieri S. Ocular alterations in alopecia areata. Eye (Lond). 1999 Oct;13 ( Pt 5):643-6. doi: 10.1038/eye.1999.174.

    PMID: 10696317BACKGROUND

  • Nischal KC, Khopkar U. Dermoscope. Indian J Dermatol Venereol Leprol. 2005 Jul-Aug;71(4):300-3. doi: 10.4103/0378-6323.16633. No abstract available.

    PMID: 16394450BACKGROUND

  • Inui S, Nakajima T, Nakagawa K, Itami S. Clinical significance of dermoscopy in alopecia areata: analysis of 300 cases. Int J Dermatol. 2008 Jul;47(7):688-93. doi: 10.1111/j.1365-4632.2008.03692.x.

    PMID: 18613874BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Eman Riad, MD

CONTACT

00201005298992E_raid@aun.edu.eg

Ayman Mohamed, MD

CONTACT

00201009948311aymanderma@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share