Dermatitis Herpetiformis Refractory to Gluten Free Diet

NCT ID: NCT05998291

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Dermatitis Herpetiformis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Refractory dermatitis herpetiformis patients

Dermatitis herpetiformis rash not controlled by strict glute-free diet

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Intervention Type 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

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Intervention Type OTHER

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Interventions

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Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaisa Hervonen, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R23003

Identifier Type: -

Identifier Source: org_study_id

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