Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05780840
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erythropoietic Protoporphyria	Other: Dihydroxyacetone; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
• Actual Study Start Date: Feb 23, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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)
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)

Outcome Measures

Primary Outcome Measures

1. Visible light exposure dose to onset of first skin symptom [Meassurement one day after dihydroxyacetone application]

   Assessed by phototesting

Secondary Outcome Measures

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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ida Marie Heerfordt	Copenhagen		Denmark	2400

Sponsors and Collaborators

• Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study protocol

Publications

None provided.

• Responsible Party: Ida M. Heerfordt, Principal Investigator, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT05780840
• Other Study ID Numbers: Dihydroxyacetone
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ida M. Heerfordt, Principal Investigator, Bispebjerg Hospital: Dihydroxyaceton; Erythropoietic protoporphyria; Light protection; Protoporphyrin IX; Self-tanning; Skin
• Additional relevant MeSH terms: Protoporphyria, Erythropoietic

Study Results

No Results Posted as of Mar 23, 2023