NCT05998291

Brief Summary

The main purpose of the study is to find out

  1. 1.the natural course of refractory dermatitis herpetiformis and the development of possible complications
  2. 2.the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

March 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

March 2, 2023

Last Update Submit

August 18, 2023

Conditions

Dermatitis Herpetiformis

Keywords

dermatitis herpetiformis, dapsone, gluten-free diet

Outcome Measures

Primary Outcomes (1)

  • Clinical prognosis

    Occurrence of complications

    Baseline

Secondary Outcomes (1)

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

    Baseline

Other Outcomes (4)

  • Microbiata

    Baseline

  • Quality of life measure DLQI

    Baseline

  • Quality of life measure BGWP

    Baseline

  • +1 more other outcomes

Study Arms (2)

Refractory dermatitis herpetiformis patients

Dermatitis herpetiformis rash not controlled by strict glute-free diet

Other: 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

Interventions

Assessment of prognosis of refractory dermatitis herpetiformis. No interventionOTHER

Assessment of prognosis of refractory dermatitis herpetiformis. No intervention

Dermatitis herpetiformis patients with good response to gluten-free dietRefractory dermatitis herpetiformis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with refractory dermatitis herpetiformis

You may qualify if:

  • 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

You may not qualify if:

  • Study patients:
  • Not following strict gluten-free diet
  • Control patients:
  • Not following a strict gluten-free diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33101, Finland

Location

MeSH Terms

Conditions

Dermatitis Herpetiformis

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VesiculobullousAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kaisa Hervonen, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2023

First Posted

August 18, 2023

Study Start

June 15, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

FI(1)