Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

Erythropoietic Protoporphyria Clinical Trial

Official title:

Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780840
• Other study ID #: Dihydroxyacetone
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Erythropoietic Protoporphyria

Intervention

Other:
• Dihydroxyacetone
Application of 10% dihydroxyacetone (2 mg per square cm skin)
• Placebo
Application of lotion to the skin (2 mg per square cm skin)

Locations

Country	Name	City	State
Denmark	Ida Marie Heerfordt	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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.

External Links

•   Study protocol