Alopecia AreataNCT07046039
The Impact of Untreated Depression and Anxiety Among Patients With Skin Diseases in Jeddah, Saudi Arabia.
An observational study of Alopecia Areata and Acne Vulgaris, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this observational study is to learn about the prevalence and severity of untreated depression and anxiety among adults with skin diseases in Jeddah, Saudi Arabia. The main question it aims to answer is: Do patients with skin diseases experience significant levels of untreated depression and anxiety?… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata, Acne Vulgaris, Psoriasis
- How many people
- 215 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2024to 29 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 65 years residing in Jeddah, Saudi Arabia, who have been diagnosed with one or more of the following dermatological conditions: acne vulgaris, atopic dermatitis (eczema), psoriasis, vitiligo, rosacea, hidradenitis suppurativa, or alopecia areata. Participants were recruited from dermatology outpatient clinics and through online social media platforms.
Who may be able to join
- Adults aged 18 to 65 years
- Residents of Jeddah, Saudi Arabia
- Diagnosed with one or more of the following skin diseases: acne vulgaris, atopic dermatitis (eczema), psoriasis, vitiligo, rosacea, hidradenitis suppurativa, or alopecia areata
- Able to complete the study questionnaire in Arabic or English
Who cannot join
- Age below 18 or above 65 years
- Absence of diagnosis for the specified skin diseases
- Presence of chronic systemic illnesses such as diabetes, cardiovascular diseases, hypertension, or epilepsy
- Inability to provide informed consent or complete the questionnaire
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University - Faculty of Medicine
Jeddah
About this study
Official title: The Impact of Untreated Depression and Anxiety in Patients With Skin Diseases: A Cross-sectional Study in Jeddah
The goal of this observational study is to learn about the prevalence and severity of untreated depression and anxiety among adults with skin diseases in Jeddah, Saudi Arabia. The main question it aims to answer is:
Do patients with skin diseases experience significant levels of untreated depression and anxiety?
Participants diagnosed with skin conditions such as acne, eczema, or psoriasis completed the PHQ-9 and GAD-7 questionnaires to assess their mental health symptoms. The study also explores whether factors like age or type of skin disease are associated with more severe psychological distress.
Read the detailed description
This cross-sectional observational study was conducted to assess the prevalence and severity of untreated depression and anxiety among adult patients diagnosed with common dermatological conditions in Jeddah, Saudi Arabia. The study focused on patients living with acne vulgaris, atopic dermatitis (eczema), psoriasis, vitiligo, rosacea, hidradenitis suppurativa, and alopecia. Conditions that are not only physically distressing but also associated with significant psychological impact.
Participants were recruited through dermatology clinics and online platforms. Standardized and validated screening tools, including the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7), were used to evaluate symptoms of depression and anxiety. Participants were eligible if they were between 18-65 years old, residing in Jeddah, and had not received prior psychiatric treatment for depression or anxiety.
The study also examined potential correlations between psychological distress and clinical or demographic variables such as age, sex, income level, education, and disease severity. Statistical analyses were conducted to identify significant predictors of untreated mental health symptoms in this population.
By quantifying the emotional burden associated with skin disease and identifying at-risk subgroups, the study aims to support the integration of routine mental health screening into dermatologic practice. The findings underscore the need for a more comprehensive, biopsychosocial approach to dermatology care in Saudi Arabia, where psychological symptoms are often underrecognized and undertreated.
- Conditions
- Alopecia Areata, Acne Vulgaris, Psoriasis, Atopic Dermatitis (Eczema), Rosacea, Hidradenitis Suppurativa (HS)
- Keywords
- Psychodermatology, Untreated mental health
- Medical subject headings
- Alopecia Areata, Acne Vulgaris, Psoriasis, Dermatitis, Atopic, Eczema, Rosacea, Hidradenitis Suppurativa, Vitiligo
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of untreated anxiety
The proportion of patients with dermatological conditions who score above the clinical threshold for anxiety on the Generalized Anxiety Disorder-7 (GAD-7) scale.
Measured: 1 day (Assessed at one point in time during the study.)
Prevalence of untreated depression
The proportion of patients with dermatological conditions who score above the clinical threshold for depression on the Patient Health Questionnaire-9 (PHQ-9).
Measured: 1 day (Assessed at one point in time during the study.)
Secondary outcomes (1)
Correlation between skin disease severity and psychological distress
Statistical assessment of the relationship between the severity of skin diseases (categorized as mild, moderate, or severe) and the levels of depression and anxiety symptoms.
Measured: 1 day (Assessed at one point in time during the study.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jan 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Omar Aljohani, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046039
- Sponsor's protocol ID
- 703-23
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Although aggregate study results will be published, individual participant data (IPD) will not be shared because no identifiable data was collected, ensuring participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Untreated Depression and Anxiety in Patients With Skin Diseases: A Cross-sectional Study in Jeddah
- ClinicalTrials.gov ID
- NCT07046039
- Acronym / sponsor ID
- 703-23
- Conditions
- Alopecia Areata, Acne Vulgaris, Psoriasis, Atopic Dermatitis (Eczema), Rosacea, Hidradenitis Suppurativa (HS)
- Keywords
- Psychodermatology, Untreated mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 1 Jul 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.
The goal of this observational study is to learn about the prevalence and severity of untreated depression and anxiety among adults with skin diseases in Jeddah, Saudi Arabia. The main question it aims to answer is:
Do patients with skin diseases experience significant levels of untreated depression and anxiety?
Participants diagnosed with skin conditions such as acne, eczema, or psoriasis completed the PHQ-9 and GAD-7 questionnaires to assess their mental health symptoms. The study also explores whether factors like age or type of skin disease are associated with more severe psychological distress.
Detailed description
This cross-sectional observational study was conducted to assess the prevalence and severity of untreated depression and anxiety among adult patients diagnosed with common dermatological conditions in Jeddah, Saudi Arabia. The study focused on patients living with acne vulgaris, atopic dermatitis (eczema), psoriasis, vitiligo, rosacea, hidradenitis suppurativa, and alopecia. Conditions that are not only physically distressing but also associated with significant psychological impact.
Participants were recruited through dermatology clinics and online platforms. Standardized and validated screening tools, including the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7), were used to evaluate symptoms of depression and anxiety. Participants were eligible if they were between 18-65 years old, residing in Jeddah, and had not received prior psychiatric treatment for depression or anxiety.
The study also examined potential correlations between psychological distress and clinical or demographic variables such as age, sex, income level, education, and disease severity. Statistical analyses were conducted to identify significant predictors of untreated mental health symptoms in this population.
By quantifying the emotional burden associated with skin disease and identifying at-risk subgroups, the study aims to support the integration of routine mental health screening into dermatologic practice. The findings underscore the need for a more comprehensive, biopsychosocial approach to dermatology care in Saudi Arabia, where psychological symptoms are often underrecognized and undertreated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 65 years residing in Jeddah, Saudi Arabia, who have been diagnosed with one or more of the following dermatological conditions: acne vulgaris, atopic dermatitis (eczema), psoriasis, vitiligo, rosacea, hidradenitis suppurativa, or alopecia areata. Participants were recruited from dermatology outpatient clinics and through online social media platforms.
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
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
Prevalence of untreated anxiety
Time frame: 1 day (Assessed at one point in time during the study.)
The proportion of patients with dermatological conditions who score above the clinical threshold for anxiety on the Generalized Anxiety Disorder-7 (GAD-7) scale.
Prevalence of untreated depression
Time frame: 1 day (Assessed at one point in time during the study.)
The proportion of patients with dermatological conditions who score above the clinical threshold for depression on the Patient Health Questionnaire-9 (PHQ-9).
1 secondary outcome
Correlation between skin disease severity and psychological distress
Time frame: 1 day (Assessed at one point in time during the study.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. Although aggregate study results will be published, individual participant data (IPD) will not be shared because no identifiable data was collected, ensuring participant privacy and confidentiality.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Alopecia Areata and Acne Vulgaris, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of untreated anxiety (time frame: 1 day (Assessed at one point in time during the study.)). The study lists 2 primary outcomes in all. 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 1 Jul 2025.