Dermatitis Herpetiformis Refractory to Gluten Free Diet

• Sponsor: Tampere University Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05998291
• Collaborator: Tampere University (Other), University of Helsinki (Other)
• Enrollment: 23
• Location: 1
• Anticipated Duration (Months): 42.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dermatitis Herpetiformis	Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 23 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia
• Actual Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Refractory dermatitis herpetiformis patients Dermatitis herpetiformis rash not controlled by strict glute-free diet	Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention; 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	Other: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention; Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Outcome Measures

Primary Outcome Measures

1. Clinical prognosis [Baseline]

   Occurrence of complications

Secondary Outcome Measures

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

   The strictness of gluten-free diet (GIP test)

Other Outcome Measures

1. Microbiata [Baseline]

   skin, oral and intestinal microbiata

2. Quality of life measure DLQI [Baseline]

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

3. 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)

4. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33101

Sponsors and Collaborators

• Tampere University Hospital
• Tampere University
• University of Helsinki

Investigators

• Principal Investigator: Kaisa Hervonen, PhD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT05998291
• Other Study ID Numbers: R23003
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Tampere University Hospital: dermatitis herpetiformis, dapsone, gluten-free diet
• Additional relevant MeSH terms: Dermatitis; Dermatitis Herpetiformis

Study Results

No Results Posted as of Aug 22, 2023