Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

NCT ID: NCT05780840

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Erythropoietic Protoporphyria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Dihydroxyacetone

Group Type EXPERIMENTAL

Dihydroxyacetone

Intervention Type OTHER

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

Placebo

Intervention Type OTHER

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

Placebo

Group Type PLACEBO_COMPARATOR

Dihydroxyacetone

Intervention Type OTHER

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

Placebo

Intervention Type OTHER

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

Interventions

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Dihydroxyacetone

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ida M. Heerfordt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ida Marie Heerfordt

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Ida M Heerfordt, MD, PhD

Role: primary

+45 38 63 50 00

Related Links

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Other Identifiers

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Dihydroxyacetone

Identifier Type: -

Identifier Source: org_study_id

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