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Enrolling by Invitation

NCT Number: NCT05998291

Dermatitis Herpetiformis Refractory to Gluten Free Diet

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

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Key information

Conditions

Dermatitis Herpetiformis Autoimmune Diseases Dermatitis Immune System Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33101, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Other

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Primary outcomes

  1. Clinical prognosis

    Time frame: Baseline

    Occurrence of complications

Secondary outcomes

  1. Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis

    Time frame: Baseline

    The strictness of gluten-free diet (GIP test)

Other outcomes

  1. Microbiata

    Time frame: Baseline

    skin, oral and intestinal microbiata

  2. Quality of life measure DLQI

    Time frame: Baseline

    DLQI (10-items, a higher score indicating lower quality of life)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University
  • University of Helsinki

Registry information

Official study title

Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 18, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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