Back to resultsProtection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Primary Purpose
Erythropoietic Protoporphyria
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dihydroxyacetone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Erythropoietic Protoporphyria focused on measuring Dihydroxyaceton, Erythropoietic protoporphyria, Light protection, Protoporphyrin IX, Self-tanning, Skin
Eligibility Criteria
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
Sites / Locations
- Ida Marie HeerfordtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dihydroxyacetone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Visible light exposure dose to onset of first skin symptom
Assessed by phototesting
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05780840
Brief Title
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Official Title
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythropoietic Protoporphyria
Keywords
Dihydroxyaceton, Erythropoietic protoporphyria, Light protection, Protoporphyrin IX, Self-tanning, Skin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dihydroxyacetone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Dihydroxyacetone
Intervention Description
Application of 10% dihydroxyacetone (2 mg per square cm skin)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Application of lotion to the skin (2 mg per square cm skin)
Primary Outcome Measure Information:
Title
Visible light exposure dose to onset of first skin symptom
Description
Assessed by phototesting
Time Frame
Meassurement one day after dihydroxyacetone application
Secondary Outcome Measure Information:
Title
Change in skin color from before treatment to one day after treatment
Description
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.
Time Frame
Meassurement of skin color just before dihydroxyacetone application and one day after application.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ida Marie Heerfordt
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida M Heerfordt, MD, PhD
Phone
+45 38 63 50 00
Email
ida.marie.heerfordt@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Yes
Links:
URL
https://doi.org/10.1016/j.pdpdt.2023.103302
Description
Study protocol
Learn more about this trial
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
We'll reach out to this number within 24 hrs