Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

March 10, 2023 updated by: Ida M. Heerfordt, Bispebjerg Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Dihydroxyacetone
Application of 10% dihydroxyacetone (2 mg per square cm skin)
Other: Placebo
Application of lotion to the skin (2 mg per square cm skin)
Experimental: Dihydroxyacetone
Other: Dihydroxyacetone
Application of 10% dihydroxyacetone (2 mg per square cm skin)
Other: Placebo
Application of lotion to the skin (2 mg per square cm skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visible light exposure dose to onset of first skin symptom
Time Frame: Meassurement one day after dihydroxyacetone application
Assessed by phototesting
Meassurement one day after dihydroxyacetone application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin color from before treatment to one day after treatment
Time Frame: 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.
Meassurement of skin color just before dihydroxyacetone application and one day after application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dihydroxyacetone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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