NCT06802705

Brief Summary

Background: Alopecia areata (AA) is an autoimmune disorder that causes non-scaring hair loss, and common psychiatric comorbidities such as depression and anxiety are often experienced among these patients. The underlying causes of this disorder, including environmental factors, immune responses, autoimmune reactions, and genetic predisposition, are still debated. This condition affects approximately 0.2% of the global population and has no specific gender preference, with an average onset age of 33 years. This study aims to assess the psychosocial impact on quality of life in individuals with alopecia areata in Saudi Arabia Methodology: This study employed a cross-sectional questionnaire survey among Alopecia areata patients, targeting both Saudi and non-Saudi participants of both genders, from October 2023 - March 2024. The sample size is determined to be 384 participants based on a confidence level of 95%. By investigating the psychological impact of AA in Saudi Arabia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 7, 2025

Last Update Submit

January 25, 2025

Conditions

Keywords

Alopecia AreataHair LossAutoimmune DisorderDermatological Conditions

Outcome Measures

Primary Outcomes (1)

  • The Impact of Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata

    For this study, sociodemographic characteristics of the participants, sources of information about alopecia areata, determinants of alopecia areata, levels of psychological stress, and the potential impact of psychological stress on the quality of life of alopecia areata patients will be presented using numbers and percentages. The association between sociodemographic variables and the risk of psychological stress will be assessed using the chi-square test. The significance level for this study is chosen before data collection, and is set to be lower than 5%.

    Baseline

Interventions

Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study population consisted of Alopecia areata patients in Saudi Arabia of both genders. Saudi and non-Saudi patients with Alopecia areata in Saudi Arabia who were at least 16 years old, of both sexes, and with all clinical forms of AA met the inclusion criteria. Patients who are below 16 years old and who were ineligible due to medical reasons, and those who had any concomitant chronic dermatological problems, were excluded.

You may not qualify if:

  • Patients who are below 16 years old and who were ineligible due to medical reasons, and those who had any concomitant chronic dermatological problems, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saud Aleissa

Jeddah, Saudi Arabia

Location

Related Publications (17)

  • Winnette R, Martin S, Harris N, Deal LS. Development of the Alopecia Areata Patient Priority Outcomes Instrument: A Qualitative Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):599-613. doi: 10.1007/s13555-021-00508-w. Epub 2021 Mar 9.

    PMID: 33751494BACKGROUND
  • Christensen T, Yang JS, Castelo-Soccio L. Bullying and Quality of Life in Pediatric Alopecia Areata. Skin Appendage Disord. 2017 Aug;3(3):115-118. doi: 10.1159/000466704. Epub 2017 Mar 24.

    PMID: 28879186BACKGROUND
  • Liu LY, King BA, Craiglow BG. Alopecia areata is associated with impaired health-related quality of life: A survey of affected adults and children and their families. J Am Acad Dermatol. 2018 Sep;79(3):556-558.e1. doi: 10.1016/j.jaad.2018.01.048. Epub 2018 Feb 7. No abstract available.

    PMID: 29425723BACKGROUND
  • Putterman E, Patel DP, Andrade G, Harfmann KL, Hogeling M, Cheng CE, Goh C, Rogers RS, Castelo-Soccio L. Severity of disease and quality of life in parents of children with alopecia areata, totalis, and universalis: A prospective, cross-sectional study. J Am Acad Dermatol. 2019 May;80(5):1389-1394. doi: 10.1016/j.jaad.2018.12.051. Epub 2019 Jan 8.

    PMID: 30633941BACKGROUND
  • Bilgic O, Bilgic A, Bahali K, Bahali AG, Gurkan A, Yilmaz S. Psychiatric symptomatology and health-related quality of life in children and adolescents with alopecia areata. J Eur Acad Dermatol Venereol. 2014 Nov;28(11):1463-8. doi: 10.1111/jdv.12315. Epub 2013 Nov 16.

    PMID: 24237476BACKGROUND
  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

    PMID: 8033378BACKGROUND
  • Abou-taleb DAE, Abd OH, Hameed E, Moubasher AEA. Journal of Clinical & Experimental Psychological Impact of Alopecia Areata on Egyptian Patients. 2021;12(1000568):1-4.

    BACKGROUND
  • Mesinkovska N, Craiglow B, Ball SG, Morrow P, Smith SG, Pierce E, Shapiro J. The Invisible Impact of a Visible Disease: Psychosocial Impact of Alopecia Areata. Dermatol Ther (Heidelb). 2023 Jul;13(7):1503-1515. doi: 10.1007/s13555-023-00941-z. Epub 2023 Jun 8.

    PMID: 37289409BACKGROUND
  • Abideen F, Valappil AT, Mathew P, Sreenivasan A, Sridharan R. Quality of life in patients with alopecia areata attending dermatology department in a tertiary care centre - A cross-sectional study. J Pakistan Assoc Dermatologists. 2018;28(2):175-80.

    BACKGROUND
  • Alzubaidy BA, Banjar TA, Almaghrabi MA, Alkidaiwi SS, Basfar LM, Alzubaidy KA, Dhafar SK, Alharbi A. Evaluation of the Awareness, Beliefs, and Psychological Impact of Patients with Alopecia Areata in Makkah City, Saudi Arabia. Adv Med. 2023 May 23;2023:4286891. doi: 10.1155/2023/4286891. eCollection 2023.

    PMID: 37260526BACKGROUND
  • Nadpara J, Tadke R, Faye A, Gawande S, Bhave S, Kirpekar V, et al. Study of anxiety in patients with moderate alopecia. Ann Indian Psychiatry. 2017;1(1):29.

    BACKGROUND
  • Jagtiani A, Nishal P, Jangid P, Sethi S, Dayal S, Kapoor A. Depression and suicidal ideation in patients with acne, psoriasis, and alopecia areata. J Ment Heal Hum Behav. 2017;22(1):50.

    BACKGROUND
  • Velez-Muniz RDC, Peralta-Pedrero ML, Jurado-Santa Cruz F, Morales-Sanchez MA. Psychological Profile and Quality of Life of Patients with Alopecia Areata. Skin Appendage Disord. 2019 Aug;5(5):293-298. doi: 10.1159/000497166. Epub 2019 Mar 20.

    PMID: 31559253BACKGROUND
  • Toussi A, Barton VR, Le ST, Agbai ON, Kiuru M. Psychosocial and psychiatric comorbidities and health-related quality of life in alopecia areata: A systematic review. J Am Acad Dermatol. 2021 Jul;85(1):162-175. doi: 10.1016/j.jaad.2020.06.047. Epub 2020 Jun 17.

    PMID: 32561373BACKGROUND
  • Titeca G, Goudetsidis L, Francq B, Sampogna F, Gieler U, Tomas-Aragones L, Lien L, Jemec GBE, Misery L, Szabo C, Linder D, Evers AWM, Halvorsen JA, Balieva F, Szepietowski J, Romanov D, Marron SE, Altunay IK, Finlay AY, Salek SS, Kupfer J, Dalgard FJ, Poot F. 'The psychosocial burden of alopecia areata and androgenetica': a cross-sectional multicentre study among dermatological out-patients in 13 European countries. J Eur Acad Dermatol Venereol. 2020 Feb;34(2):406-411. doi: 10.1111/jdv.15927. Epub 2019 Nov 12.

    PMID: 31465592BACKGROUND
  • Disturbed sleep quality and increased depression scores in alopecia areata patients Aynure Oztekin, Coskun Oztekin.

    BACKGROUND
  • Mirza MA, Jung SJ, Sun W, Qureshi AA, Cho E. Association of depression and alopecia areata in women: A prospective study. J Dermatol. 2021 Aug;48(8):1296-1298. doi: 10.1111/1346-8138.15931. Epub 2021 Jun 14. No abstract available.

    PMID: 34128269BACKGROUND

MeSH Terms

Conditions

Alopecia AreataAlopeciaAutoimmune Diseases

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Saud Aleissa

    MD FAAD, Assistant Professor, King Abdulaziz University and University Hospital, Jeddah, Saudi Arabia.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 31, 2025

Study Start

October 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations