NCT03682731

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

September 21, 2018

Last Update Submit

October 1, 2018

Conditions

Erythropoietic Protoporphyria

Outcome Measures

Primary Outcomes (1)

  • Actual light exposure

    Actual light exposure of patients with erythropoietic protoporphyria

    from April through June 2017

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with erythropoietic protoporphyria.

You may qualify if:

  • Diagnosed with erythropoietic protoporphyria
  • Informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

Location

MeSH Terms

Conditions

Protoporphyria, Erythropoietic

Condition Hierarchy (Ancestors)

Porphyrias, HepaticLiver DiseasesDigestive System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPorphyriasMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

April 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

DK(2)