Dermatitis Herpetiformis Refractory to Gluten Free Diet

Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05998291

Enrollment

Registered

2023-08-18

Start date

2023-06-15

Completion date

2026-12-31

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis Herpetiformis

Keywords

dermatitis herpetiformis, dapsone, gluten-free diet

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.

Interventions

OTHERAssessment of prognosis of refractory dermatitis herpetiformis. No intervention

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical prognosis	Baseline	Occurrence of complications

Secondary

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

Other

Measure	Time frame	Description
Microbiata	Baseline	skin, oral and intestinal microbiata
Quality of life measure DLQI	Baseline	DLQI (10-items, a higher score indicating lower quality of life)
Quality of life measure BGWP	Baseline	PGWP (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)
Gastrointestinal symptoms GSRS	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)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026