NCT06801821

Brief Summary

Primary objective: The primary objective is to evaluate in the general population the difference between emotional reactions associated with facial involvement by four major dermatologic diseases: psoriasis, atopic dermatitis, vitiligo, and alopecia areata.

  • Compare the social distance and stereotyping by the general population toward individuals with facial involvement by: psoriasis, atopic dermatitis, vitiligo, and alopecia areata.
  • Evaluate demographic factors that describe a greater tendency toward stigmatization.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 26, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 24, 2025

Last Update Submit

August 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary endopoint

    Compare the percentage of patients associating the 4 different emotional reactions analyzed (compassion/pity, disgust, blame/disapproval/dislike, and curiosity) with each dermatologic condition under study.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The intent of this observational study is primarily descriptive. It is estimated to be able to enroll 400 subjects adhering to the inclusion and exclusion criteria under treatment at the dermatology laboratory. Patients will be enrolled consecutively from 01-02-2025 to 01-02-2026. The 400 patients will answer initial questions about the emotional reactions induced by the 4 diseases and SYNOPSIS\_STYGMADERM Study Version 1.0 on 03.10.24 Page 4 of 6 then will answer the questionnaire on stigma toward only one of the 4 dermatologic diseases under study (100 will answer the questionnaire on atopic dermatitis, 100 on alopecia areata, 100 on vitiligo, and 100 on psoriasis).

You may qualify if:

  • Patients aged\>18 years, both sexes;
  • Signature of written informed consent;

You may not qualify if:

  • Patients diagnosed with psoriasis, atopic dermatitis, vitiligo or alopecia areata.
  • Patients with first-degree relatives with psoriasis, atopic dermatitis, vitiligo or alopecia areata
  • Those who for professional or personal reasons have direct knowledge of the diseases in question.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia

Roma, Italia, 00168, Italy

RECRUITING

MeSH Terms

Conditions

PsoriasisVitiligoDermatitis, AtopicAlopecia

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesHypopigmentationPigmentation DisordersSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypotrichosisHair DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Giacomo Caldarola, MD

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-01

Locations