NCT07521813

Brief Summary

The aim of this study:

  1. 1.Evaluate the presence of body dysmorphic disorder in children with dermatological diseases compared to healthy controls.
  2. 2.Assess the effect of these skin diseases on the quality of life in those children.

Trial Health

65
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Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress4%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Body Dysmorphic Disorder in Children with Dermatological Diseases

    Evaluate the presence of body dysmorphic disorder in children with dermatological diseases compared to healthy controls. The study will include 250 children of both sexes aged from six to less than 18 years presented with various chronic skin diseases, diagnosed clinically , by dermoscopy and by biopsy if needed, and 250 age and sex matched healthy controls . Assessment of the severity of the dermatological diseases according to available valid severity scores will be done . Body Dysmorphic Disorder Questionnaire Dermatology Version will be done to identify symptoms of body dysmorphic disorder with valid standardized arabic version . The body dysmorphic disorder questionnaire is a brief, validated questionnaire used to identify patients having symptoms of BDD. It uses close-ended questions and identifies if participants' concerns regarding appearance are a source of preoccupation and identifies the grade of distress or interference with social and occupational functioning .

    From Apri 2026 to April 2027

  • Assess the effect of skin diseases on the quality of life of children

    Assess the effect of skin diseases on the quality of life in children by using Children's Dermatology Life Quality Index questionnaire (CDLQI) that used to evaluate the psychosocial impact of skin disease with valid standardized Arabic version . The study will include 250 children of both sexes aged from six up to less than 18 years presenting with various chronic skin diseases, diagnosed clinically, by dermoscopy and by biopsy if needed, and 250 age and sex matched healthy controls then Children's Dermatology Life Quality Index questionnaire (CDLQI) will be assessed with a valid standardized Arabic version . The Children's Dermatology Life Quality Index (CDLQI) is a validated questionnaire to assess the impact of skin diseases on the quality of life of children. It evaluates the effect of dermatological conditions on physical symptoms, emotional well-being, daily activities, social interactions, school performance, and treatment.

    From April 2026 to April 2027

Interventions

The Body Dysmorphic Disorder Questionnaire (BDDQ) : The BDD-Q is a brief, validated self-administered questionnaire that is used to identify patients having symptoms of BDD. It uses close-ended questions and identifies if participants' concerns regarding appearance are a source of preoccupation. It also identifies the grade of distress or interference with social and occupational functioning caused by these concerns . It has good validity, high sensitivity (100%) and specificity (89- 93%) for screening for BDD . BDD diagnosis is likely if answers to question (1) (preoccupation) are yes to both parts, answers to question 3 (significant stress) include yes to any of the questions and answers to question (4) (time spent thinking about defect) include b or c choices.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include 250 patients with dermatological diseases and 250 age and sex matched healthy controls. From Dermatology outpatient clinics, Sohag University Hospitals, Faculty of Medicine Sohag University.

You may qualify if:

  • The study will include 250 children of both sexes aged from six up to less than 18 years presenting with various chronic skin diseases, diagnosed clinically, by dermoscopy and by biopsy if needed, and age and sex matched healthy controls.
  • Ability of the child and caregiver to understand and respond to the questionnaires.

You may not qualify if:

  • Children with diagnosed psychiatric disorders other than BDD (e.g., severe depression, autism spectrum disorder).
  • Children with chronic systemic illness affecting body image or any other debilitating acute , chronic illness or surgical problems e.g.: short stature, hypothyroidism, osteochondral defects and obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Arumugham SS, Narayanaswamy JC, Balachander S, Sharma E, Jaisoorya TS, Reddy SC, Siddiqui AM, Desouza A, Shah PS, Reddy YJ. Clinical practice guidelines for obsessive-compulsive disorder: 2025 update. Indian J Psychiatry. 2026 Jan;68(1):44-67. doi: 10.4103/indianjpsychiatry_1259_25. Epub 2026 Jan 27.

    PMID: 41694048BACKGROUND
  • Ruck C, Mataix-Cols D, Feusner JD, Shavitt RG, Veale D, Krebs G, Fernandez de la Cruz L. Body dysmorphic disorder. Nat Rev Dis Primers. 2024 Dec 5;10(1):92. doi: 10.1038/s41572-024-00577-z.

    PMID: 39639018BACKGROUND
  • Sa B, Khalil N, Edwards E, Smith A, Franca K. Pediatric Psychodermatology: Advancing Therapy through Integrated Care. Dermatol Ther (Heidelb). 2026 Mar;16(3):1455-1472. doi: 10.1007/s13555-026-01673-6. Epub 2026 Feb 16.

    PMID: 41697633BACKGROUND
  • Salari N, Heidarian P, Hosseinian-Far A, Babajani F, Mohammadi M. Global Prevalence of Anxiety, Depression, and Stress Among Patients with Skin Diseases: A Systematic Review and Meta-analysis. J Prev (2022). 2024 Aug;45(4):611-649. doi: 10.1007/s10935-024-00784-0. Epub 2024 Jun 1.

    PMID: 38822990BACKGROUND

MeSH Terms

Interventions

Surveys and QuestionnairesRestraint, Physical

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Soha Hishmat Aboeldahab, Professor

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Aya Abdelhaseb Abdellatif, Resident doctor

CONTACT

Zeinab Abuelbaha Gouda, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of dermatology

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share