Protection Against Visible Light by Dihydroxyacetone in E... | NCT05780840

Studies
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria

NCT05780840

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Mar 23, 2023Actual

Enrollment

6Estimated

Phase

Not Applicable

Conditions

Erythropoietic Protoporphyria

Interventions

Dihydroxyacetone
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2023Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Mar 10, 2023

First Posted Date

Mar 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2023

Last Update Posted Date

Mar 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dihydroxyacetone	Experimental		Other: Dihydroxyacetone Other: Placebo
Placebo	Placebo Comparator		Other: Dihydroxyacetone Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dihydroxyacetone	Other	Application of 10% dihydroxyacetone (2 mg per square cm skin)	Dihydroxyacetone Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.	Meassurement of skin color just before dihydroxyacetone application and one day after application.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ida Marie Heerfordt	Recruiting	Copenhagen		2400	Denmark

Label	URL
Study protocol	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046351	Protoporphyria, Erythropoietic

Ancestor Terms

ID	Term
D017094	Porphyrias, Hepatic
D008107	Liver Diseases
D004066	Digestive System Diseases
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004098	Dihydroxyacetone

Ancestor Terms

ID	Term
D007661	Ketoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D014306

Browse Leaves

Not provided

Browse Branches

Not provided