Erythropoietic Protoporphyria Clinical Trial
Official title:
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Verified date | March 2023 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
What is the visible light protective effect of dihydroxyacetone in individuals with erythropoietic protoporphyria? This will be tested in this randomized blinded placebo controlled study.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with erythropoietic protoporphyria - At least 18 years of age - Obtainment of written informed consent Exclusion Criteria: - Pregnant or breastfeeding - Use of dihydroxyacetone at the treatment or placebo fields within the last two week - Sun exposure of the treatment or placebo fields within the last two week - Use of suncreen or other local treatment on the treatment or placebo fields during the study period (two days) - Allergy to adhesive bandages, dihydroxyacetone or lotion |
Country | Name | City | State |
---|---|---|---|
Denmark | Ida Marie Heerfordt | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visible light exposure dose to onset of first skin symptom | Assessed by phototesting | Meassurement one day after dihydroxyacetone application | |
Secondary | Change in skin color from before treatment to one day after treatment | Assessed by color scale. The color scale is presented in DOI: 10.1111/phpp.12458.
It is a seven-point scale to assess skin color from light to dark. We expect that a large change in skin color will give the best effect. |
Meassurement of skin color just before dihydroxyacetone application and one day after application. |
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