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

  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

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

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

Tampere University Hospital

Collaborators

University of Helsinki
Tampere University

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

Keywords

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.

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