Erythropoietic Protoporphyria
Conditions
Keywords
Dihydroxyaceton, Erythropoietic protoporphyria, Light protection, Protoporphyrin IX, Self-tanning, Skin
Brief summary
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.
Interventions
OTHERDihydroxyacetone
Application of 10% dihydroxyacetone (2 mg per square cm skin)
OTHERPlacebo
Application of lotion to the skin (2 mg per square cm skin)
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visible light exposure dose to onset of first skin symptom | Meassurement one day after dihydroxyacetone application | Assessed by phototesting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin color from before treatment to one day after treatment | Meassurement of skin color just before dihydroxyacetone application and one day after application. | 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. |
Countries
Denmark
Outcome results
None listed