Dermatitis HerpetiformisNCT05998291
Dermatitis Herpetiformis Refractory to Gluten Free Diet
An observational study of Dermatitis Herpetiformis, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The main purpose of the study is to find out 1. the natural course of refractory dermatitis herpetiformis and the development of possible complications 2. the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis Herpetiformis
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jun 2023to 31 Dec 2026
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with refractory dermatitis herpetiformis
Who may be able to join
- Study patients:
- Dermatitis herpetiformis diagnosis
- Dermatitis herpetiformis rash not responding to a strict gluten-free diet after at least 3 years
- Control patients:
- Dermatitis herpetiformis diagnosis
- Dermatitis herpetiformis with good response to a gluten-free diet
Who cannot join
- Study patients:
- -Not following strict gluten-free diet
- Control patients:
- -Not following a strict gluten-free diet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia
The main purpose of the study is to find out
- the natural course of refractory dermatitis herpetiformis and the development of possible complications
- the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis
Read the detailed description
Refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to gluten-free diet therapy. So far, there is very little knowledge on the course of the disease and the causes and prognosis of refractory celiac disease.
Study patients with refractory dermatitis herpetiformis will be recruited. As a control material dermatitis herpetiformis patients with good response to gluten-free dietary treatment will be recruited.
- Conditions
- Dermatitis Herpetiformis
- Being tested
- Assessment of prognosis of refractory dermatitis herpetiformis. No intervention
- Keywords
- dermatitis herpetiformis, dapsone, gluten-free diet
- Medical subject headings
- Dermatitis Herpetiformis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of prognosis of refractory dermatitis herpetiformis. No interventionOther
Assessment of prognosis of refractory dermatitis herpetiformis. No intervention
| Study group | Role | What they receive |
|---|---|---|
| Refractory dermatitis herpetiformis patients | Dermatitis herpetiformis rash not controlled by strict glute-free diet Receives: Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention | |
| Dermatitis herpetiformis patients with good response to gluten-free diet | Dermatitis herpetiformis rash controlled by strict glute-free diet Receives: Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical prognosis
Occurrence of complications
Measured: Baseline
Secondary outcomes (1)
Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis
The strictness of gluten-free diet (GIP test)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start15 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis HerpetiformisStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Kaisa Hervonen, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998291
- Sponsor's protocol ID
- R23003
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia
- ClinicalTrials.gov ID
- NCT05998291
- Acronym / sponsor ID
- R23003
- Conditions
- Dermatitis Herpetiformis
- Keywords
- dermatitis herpetiformis, dapsone, gluten-free diet
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2023 (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 main purpose of the study is to find out
- the natural course of refractory dermatitis herpetiformis and the development of possible complications
- the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis
Detailed description
Refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to gluten-free diet therapy. So far, there is very little knowledge on the course of the disease and the causes and prognosis of refractory celiac disease.
Study patients with refractory dermatitis herpetiformis will be recruited. As a control material dermatitis herpetiformis patients with good response to gluten-free dietary treatment will be recruited.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refractory dermatitis herpetiformis patients | – | Other: Assessment of prognosis of refractory dermatitis herpetiformis. No interventionDermatitis herpetiformis rash not controlled by strict glute-free diet |
| Dermatitis herpetiformis patients with good response to gluten-free diet | – | Other: Assessment of prognosis of refractory dermatitis herpetiformis. No interventionDermatitis herpetiformis rash controlled by strict glute-free diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with refractory dermatitis herpetiformis
Key inclusion criteria (6 listed)
- Dermatitis herpetiformis diagnosis
- Dermatitis herpetiformis rash not responding to a strict gluten-free diet after at least 3 years
- Dermatitis herpetiformis diagnosis
- Dermatitis herpetiformis with good response to a gluten-free diet
Key exclusion criteria (4 listed)
- -Not following strict gluten-free diet
- -Not following a strict gluten-free diet
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 |
|---|---|---|
| Assessment of prognosis of refractory dermatitis herpetiformis. No interventionAssessment of prognosis of refractory dermatitis herpetiformis. No intervention | Other | Dermatitis herpetiformis patients with good response to gluten-free diet, Refractory dermatitis herpetiformis patients |
Primary outcome
Clinical prognosis
Time frame: Baseline
Occurrence of complications
1 secondary outcome
Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis
Time frame: Baseline
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 22 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Dermatitis Herpetiformis
RecruitingObservational study
Background of Different Phenotypes of Coeliac Disease
Celiac Disease, Dermatitis Herpetiformis
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.
Kaisa Hervonen, PhD principal investigator
Tampere University Hospital
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 Dermatitis Herpetiformis, run by Tampere University Hospital at 1 site in Finland.
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 6 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: enrolling by invitation, as of the sponsor's last update on 22 Aug 2023. 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 Finland. 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?
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?
Clinical prognosis (time frame: Baseline). 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 22 Aug 2023.