Dermatitis Herpetiformis Refractory to Gluten Free Diet

Dermatitis Herpetiformis Clinical Trial

Official title:

Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05998291
• Other study ID #: R23003
• Status: Enrolling by invitation
• Start date: June 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 23
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Herpetiformis

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiata	skin, oral and intestinal microbiata	Baseline
Other	Quality of life measure DLQI	DLQI (10-items, a higher score indicating lower quality of life)	Baseline
Other	Quality of life measure BGWP	PGWP (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)	Baseline
Other	Gastrointestinal symptoms GSRS	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
Primary	Clinical prognosis	Occurrence of complications	Baseline
Secondary	Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis	The strictness of gluten-free diet (GIP test)	Baseline