Dermatitis Herpetiformis Refractory to Gluten Free Diet

• Conditions: Dermatitis Herpetiformis
• Interventions: Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

• Registration Number: NCT05998291
• Lead Sponsor: Tampere University Hospital

Brief 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

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 Timeline

• Study First Submitted: 2023-03-02
• Study Start: 2023-06-15
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-18
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Refractory dermatitis herpetiformis patients	Assessment of prognosis of refractory dermatitis herpetiformis. No intervention	Dermatitis herpetiformis rash not controlled by strict glute-free diet
Dermatitis herpetiformis patients with good response to gluten-free diet	Assessment of prognosis of refractory dermatitis herpetiformis. No intervention	Dermatitis herpetiformis rash controlled by strict glute-free diet

Primary Outcome Measures

Name	Time	Method
Clinical prognosis	Baseline	Occurrence of complications

Secondary Outcome Measures

Name	Time	Method
Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis	Baseline	The strictness of gluten-free diet (GIP test)

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland