Dermatitis Herpetiformis Refractory to Gluten Free Diet
August 18, 2023 updated by: Tampere University Hospital
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
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tampere, Finland, 33101
- Tampere University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with refractory dermatitis herpetiformis
Description
Inclusion Criteria:
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
Exclusion Criteria:
Study patients:
-Not following strict gluten-free diet
Control patients:
-Not following a strict gluten-free diet
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Refractory dermatitis herpetiformis patients
Dermatitis herpetiformis rash not controlled by strict glute-free diet
|
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
|
Assessment of prognosis of refractory dermatitis herpetiformis.
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical prognosis
Time Frame: Baseline
|
Occurrence of complications
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis
Time Frame: Baseline
|
The strictness of gluten-free diet (GIP test)
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiata
Time Frame: Baseline
|
skin, oral and intestinal microbiata
|
Baseline
|
|
Quality of life measure DLQI
Time Frame: Baseline
|
DLQI (10-items, a higher score indicating lower quality of life)
|
Baseline
|
|
Quality of life measure BGWP
Time Frame: Baseline
|
PGWP (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)
|
Baseline
|
|
Gastrointestinal symptoms GSRS
Time Frame: Baseline
|
GSRS (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kaisa Hervonen, PhD, Tampere University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 2, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R23003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.