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NCT03682731 Clinical Trial

Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Erythropoietic Protoporphyria Clinical Trial

Official title:
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03682731
Other study ID # Erythropoietic protoporphyria
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date August 1, 2017

Study information
Verified date September 2018
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date August 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with erythropoietic protoporphyria

- Informed consent

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen
Denmark Bispebjerg Hospital Copenhagen NV

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Actual light exposure Actual light exposure of patients with erythropoietic protoporphyria from April through June 2017
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT05308472 - Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP Phase 2
Completed NCT00004831 - Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria N/A
Completed NCT05572125 - Iron Therapy in Erythropoietic Protoporphyria
Completed NCT01605136 - Phase III Confirmatory Study in Erythropoietic Protoporphyria Phase 3
Completed NCT01422915 - Sorbent Therapy of the Cutaneous Porphyrias Phase 2/Phase 3
Completed NCT04053270 - Multicentre Phase III Erythropoietic Protoporphyria Study Phase 3
Completed NCT00004940 - Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria Phase 3
Recruiting NCT06388642 - Pharmacokinetics of Afamelanotide in EPP Patients Phase 1/Phase 2
Recruiting NCT05020184 - Effect of Oral Cimetidine in the Protoporphyrias Phase 2
Completed NCT01688895 - Erythropoietic Protoporphyrias: Studies of the Natural History, Genotype-Phenotype Correlations, and Psychosocial Impact
Completed NCT04578496 - A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) Phase 3
Recruiting NCT00206869 - Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria N/A
Recruiting NCT05780840 - Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria N/A
Completed NCT02979249 - Oral Iron for Erythropoietic Protoporphyrias N/A
Enrolling by invitation NCT05883748 - Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP Phase 2/Phase 3
Completed NCT01097044 - Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Phase 2