NCT05780840

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

February 22, 2023

Last Update Submit

March 10, 2023

Conditions

Erythropoietic Protoporphyria

Keywords

DihydroxyacetonErythropoietic protoporphyriaLight protectionProtoporphyrin IXSelf-tanningSkin

Outcome Measures

Primary Outcomes (1)

  • Visible light exposure dose to onset of first skin symptom

    Assessed by phototesting

    Meassurement one day after dihydroxyacetone application

Secondary Outcomes (1)

  • 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.

Study Arms (2)

Dihydroxyacetone

EXPERIMENTAL
Other: DihydroxyacetoneOther: Placebo

Placebo

PLACEBO COMPARATOR
Other: DihydroxyacetoneOther: Placebo

Interventions

DihydroxyacetoneOTHER

Application of 10% dihydroxyacetone (2 mg per square cm skin)

DihydroxyacetonePlacebo
PlaceboOTHER

Application of lotion to the skin (2 mg per square cm skin)

DihydroxyacetonePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with erythropoietic protoporphyria
  • At least 18 years of age
  • Obtainment of written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ida Marie Heerfordt

Copenhagen, 2400, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Protoporphyria, Erythropoietic

Interventions

Dihydroxyacetone

Condition Hierarchy (Ancestors)

Porphyrias, HepaticLiver DiseasesDigestive System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPorphyriasMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

KetosesMonosaccharidesSugarsCarbohydratesTrioses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 23, 2023

Study Start

February 23, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Locations

DK(1)