Psoriasis (PsO)STIGMADERMNCT06801821
Evaluation of Stigma Toward Patients With Alopecia Areata, Atopic Dermatitis, Vitiligo, and Psoriasis
An observational study of Psoriasis (PsO) and Vitiligo Vulgaris, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO), Vitiligo Vulgaris, Atopic Dermatitis
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- -Patients aged>18 years, both sexes;
- Signature of written informed consent;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
Roma, Italia, 00168
Giacomo Caldarola, MD, +390630155284, giacomo.caldarola@policlinicogemelli.it
Giacomo Caldarola, MD
About this study
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.
Read the detailed description
Basic demographic characteristics (Gender, Age, Employment status, Education level) will be recorded for each patient.
Participants will be asked to observe images depicting faces of individuals with atopic dermatitis, alopecia areata, vitiligo, and psoriasis (generated through artificial intelligence systems). They will be asked to select the individual from those shown that generates the most compassion/pity, disgust, blame/disapproval/disdain, and curiosity for them, analyzing the same emotional responses investigated in a study on stigma toward psoriasis patients.
In addition, each participant will be given a 14-question questionnaire on stigma (analyzing social distance and stereotyping) toward one of the four diseases under investigation (psoriasis, atopic dermatitis, vitiligo, or alopecia areata), selected randomly. For each question, responses will be expressed from 1 to 5, on a Likert scale, with lower scores indicating greater stigma. (Total score between 14 and 70)
- Conditions
- Psoriasis (PsO), Vitiligo Vulgaris, Atopic Dermatitis, Areata Alopecia
- Medical subject headings
- Psoriasis, Vitiligo, Dermatitis, Atopic, Alopecia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomo Caldarola, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801821
- Sponsor's protocol ID
- 7261
- Acronym
- STIGMADERM
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stigma Toward Patients With Alopecia Areata, Atopic Dermatitis, Vitiligo, and Psoriasis
- ClinicalTrials.gov ID
- NCT06801821
- Acronym / sponsor ID
- STIGMADERM / 7261
- Conditions
- Psoriasis (PsO), Vitiligo Vulgaris, Atopic Dermatitis, Areata Alopecia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Basic demographic characteristics (Gender, Age, Employment status, Education level) will be recorded for each patient.
Participants will be asked to observe images depicting faces of individuals with atopic dermatitis, alopecia areata, vitiligo, and psoriasis (generated through artificial intelligence systems). They will be asked to select the individual from those shown that generates the most compassion/pity, disgust, blame/disapproval/disdain, and curiosity for them, analyzing the same emotional responses investigated in a study on stigma toward psoriasis patients.
In addition, each participant will be given a 14-question questionnaire on stigma (analyzing social distance and stereotyping) toward one of the four diseases under investigation (psoriasis, atopic dermatitis, vitiligo, or alopecia areata), selected randomly. For each question, responses will be expressed from 1 to 5, on a Likert scale, with lower scores indicating greater stigma. (Total score between 14 and 70)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- -Patients aged>18 years, both sexes;
- Signature of written informed consent;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary endopoint
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Caldarola, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis (PsO) and Vitiligo Vulgaris, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caldarola (+390630155284, giacomo.caldarola@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endopoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.