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Enrolling by invitation NCT05998291

Dermatitis Herpetiformis Refractory to Gluten Free Diet

— Observational Dermatitis Herpetiformis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention.
Who it may be relevant to
Registry conditions: Dermatitis Herpetiformis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia

Overview

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

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.

Interventions

  • Other Assessment of prognosis of refractory dermatitis herpetiformis. No intervention
    Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Primary outcome measures

  • Clinical prognosis [Time frame: Baseline]
Secondary outcome measures (1)
  • Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Finland · 1 center
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT05998291 · R23003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗