Alopecia AreataDerma-001NCT06319781
A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo
An observational study of Alopecia Areata and Vitiligo, run by Blueskin AS at 3 sites in Denmark.
Trial summary
The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata, Vitiligo, Atopic Dermatitis
- What is being tested?
- Observational
- How many people
- 370 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Dec 2023to May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Minimum 18 years of age with either Atopic dermatitis, Alopecia areata, Psoriasis or Vitiligo.
Who may be able to join
- Adult subjects >18 years of age at screening.
- Previous diagnosis by a physician of atopic dermatitis, psoriasis, vitiligo, or alopecia areata.
- Visible lesions and willingness to photograph weekly using their smartphone
- Availability of a smartphone
Who cannot join
- Has any physical attributes or skin conditions that in the opinion of the investigator might interfere with the evaluation of lesions (i.e., pigmentation, tattoos, extensive scarring, excessive hair growth or acne)
- Has other clinically relevant illness that could interfere with healing of lesions (e.g. keloid scaring)
- Current or previous malignant disease, including malignant melanoma and basal cell carcinoma, within 5 years
- Some patients may have more than one of the four conditions. This is not an exclusion criterion per se but must be recorded.
Trial locations and contacts
3 sites in 1 country.
Asger Reinstrup Bihlet, PhD contact
Denmark3 sites, 3 recruiting
- Recruiting
Sanos Clinic, Gandrup
Gandrup, 9362
Cecilie Rovsing, MD, +45 7370 8220, info.nordjylland@sanosclinic.com
- Recruiting
Sanos Clinic, Herlev
Herlev, 2730
Zarqa Ali, PhD, +45 7370 8200, info@sanosclinic.com
- Recruiting
Sanos Clinic, Vejle
Vejle, 7100
Randi Kviesgaard Bechmann, MD, +45 7370 8210, info.syddanmark@sanosclinic.com
About this study
Official title: A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo / Et Pilot-kohortestudie om Risikofaktorer og Nye Metoder Til at Vurdere hudlæsioner Hos Voksne Med Atopisk Dermatitis, Alopecia Areata, Psoriasis Eller Vitiligo
The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment.
- Conditions
- Alopecia Areata, Vitiligo, Atopic Dermatitis, Psoriasis
- Being tested
- Observational
- Medical subject headings
- Alopecia Areata, Vitiligo, Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
The study is a prospective non-interventional, observational study.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis | In addition to all other "basis" assessments, subjects diagnosed with AD are to complete the following forms: EASI, vIGA-AD, SCORAD, TIS, and POEM. Receives: Other: Observational | |
| Alopecia areata | In addition to all other "basis" assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS Receives: Other: Observational | |
| Psoriasis | In addition to all other "basis" assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI Receives: Other: Observational | |
| Vitiligo | In addition to all other "basis" assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of the disease.
Descriptive changes in relevant disease activity scores over the study period
Measured: 52 weeks
Clinical characteristics and disease activity.
Association/correlations of clinical characteristics (age, sex, body-mass index, baseline disease activity score, disease duration etc.) with disease activity/flares
Measured: 52 weeks
Tissue profiling and disease activity.
Changes in tissue profiling and associations with disease activity based on relevant analyses of skin punch biopsies and standard disease activity scoring scales as listed below
Measured: 52 weeks
Disease activity and biomarkers.
Associations of patient-reported treatment regimens and disease activity parameters, and relevant parameters derived from serum and skin biopsy biomarkers
Measured: 52 weeks
Quality of life.
Changes from baseline in quality of life as analyzed by the WHOQOL-BREF
Measured: 52 weeks
Compliance of remote tasks.
Proportional compliance in % with required self-assessments and photo acquisitions during the study period
Measured: 52 weeks
Quality of smartphone collected photos.
Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment
Measured: 52 weeks
Level of agreement between the in-person and remote scoring
Level of agreement between the in-person and remote scoring, inter- and intrareliability, subsequent bias (average of differences) and precision estimates on the average difference between the scorings evaluated by the raters from remote and in-person, from the changes from baseline in relevant disease activity scores
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Dec 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blueskin AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zarqa Ali, MD, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319781
- Sponsor's protocol ID
- H-23038433
- Acronym
- Derma-001
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo / Et Pilot-kohortestudie om Risikofaktorer og Nye Metoder Til at Vurdere hudlæsioner Hos Voksne Med Atopisk Dermatitis, Alopecia Areata, Psoriasis Eller Vitiligo
- ClinicalTrials.gov ID
- NCT06319781
- Acronym / sponsor ID
- Derma-001 / H-23038433
- Conditions
- Alopecia Areata, Vitiligo, Atopic Dermatitis, Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Blueskin ASIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Mar 2024 (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 objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis | – | Other: ObservationalIn addition to all other "basis" assessments, subjects diagnosed with AD are to complete the following forms: EASI, vIGA-AD, SCORAD, TIS, and POEM. |
| Alopecia areata | – | Other: ObservationalIn addition to all other "basis" assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS |
| Psoriasis | – | Other: ObservationalIn addition to all other "basis" assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI |
| Vitiligo | – | Other: ObservationalIn addition to all other "basis" assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Minimum 18 years of age with either Atopic dermatitis, Alopecia areata, Psoriasis or Vitiligo.
Key inclusion criteria (4 listed)
- Adult subjects >18 years of age at screening.
- Previous diagnosis by a physician of atopic dermatitis, psoriasis, vitiligo, or alopecia areata.
- Visible lesions and willingness to photograph weekly using their smartphone
- Availability of a smartphone
Key exclusion criteria (4 listed)
- Has any physical attributes or skin conditions that in the opinion of the investigator might interfere with the evaluation of lesions (i.e., pigmentation, tattoos, extensive scarring, excessive hair growth or acne)
- Has other clinically relevant illness that could interfere with healing of lesions (e.g. keloid scaring)
- Current or previous malignant disease, including malignant melanoma and basal cell carcinoma, within 5 years
- Some patients may have more than one of the four conditions. This is not an exclusion criterion per se but must be recorded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThe study is a prospective non-interventional, observational study. | Other | Alopecia areata, Atopic dermatitis, Psoriasis, Vitiligo |
Primary outcome
Severity of the disease.
Time frame: 52 weeks
Descriptive changes in relevant disease activity scores over the study period
Clinical characteristics and disease activity.
Time frame: 52 weeks
Association/correlations of clinical characteristics (age, sex, body-mass index, baseline disease activity score, disease duration etc.) with disease activity/flares
Tissue profiling and disease activity.
Time frame: 52 weeks
Changes in tissue profiling and associations with disease activity based on relevant analyses of skin punch biopsies and standard disease activity scoring scales as listed below
Disease activity and biomarkers.
Time frame: 52 weeks
Associations of patient-reported treatment regimens and disease activity parameters, and relevant parameters derived from serum and skin biopsy biomarkers
Quality of life.
Time frame: 52 weeks
Changes from baseline in quality of life as analyzed by the WHOQOL-BREF
Compliance of remote tasks.
Time frame: 52 weeks
Proportional compliance in % with required self-assessments and photo acquisitions during the study period
Quality of smartphone collected photos.
Time frame: 52 weeks
Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment
Level of agreement between the in-person and remote scoring
Time frame: 52 weeks
Level of agreement between the in-person and remote scoring, inter- and intrareliability, subsequent bias (average of differences) and precision estimates on the average difference between the scorings evaluated by the raters from remote and in-person, from the changes from baseline in relevant disease activity scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Asger Reinstrup Bihlet, PhD contact
Zarqa Ali, MD, PhD principal investigator
Bispebjerg Hospital
3 sites 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 Vitiligo, run by Blueskin AS at 3 sites in Denmark.
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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Castillo Mondragón, MD (+4550376106, amo@nbcd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of the disease. (time frame: 52 weeks). The study lists 8 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 20 Mar 2024.