Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

Not Applicable

Recruiting

• Conditions: Erythropoietic Protoporphyria
• Interventions: Other: Dihydroxyacetone; Other: Placebo

• Registration Number: NCT05780840
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study Start: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Dihydroxyacetone	-
Dihydroxyacetone	Placebo	-
Placebo	Placebo	-
Dihydroxyacetone	Dihydroxyacetone	-

Primary Outcome Measures

Name	Time	Method
Visible light exposure dose to onset of first skin symptom	Meassurement one day after dihydroxyacetone application	Assessed by phototesting

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ida Marie Heerfordt; 🇩🇰 Copenhagen, Denmark