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Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03682731
Collaborator
(none)
14
Enrollment
2
Locations
4
Actual Duration (Months)
7
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria
    Actual Study Start Date :
    Apr 1, 2017
    Actual Primary Completion Date :
    Aug 1, 2017
    Actual Study Completion Date :
    Aug 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Actual light exposure [from April through June 2017]

      Actual light exposure of patients with erythropoietic protoporphyria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with erythropoietic protoporphyria

    • Informed consent

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital Copenhagen NV Denmark DK-2400
    2 Bispebjerg Hospital Copenhagen Denmark

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ida M. Heerfordt, Principal Investigator, MD, PhD, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT03682731
    Other Study ID Numbers:
    • Erythropoietic protoporphyria
    First Posted:
    Sep 25, 2018
    Last Update Posted:
    Oct 2, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Protoporphyria, Erythropoietic

    Study Results

    No Results Posted as of Oct 2, 2018