Erythropoietic ProtoporphyriaNCT05780840
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
A study testing Dihydroxyacetone in people with Erythropoietic Protoporphyria, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythropoietic Protoporphyria
- What is being tested?
- Dihydroxyacetone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with erythropoietic protoporphyria
- At least 18 years of age
- Obtainment of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Ida Marie Heerfordt
Copenhagen, 2400
Ida M Heerfordt, MD, PhD, +45 38 63 50 00, ida.marie.heerfordt@regionh.dk
About this study
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.
- Conditions
- Erythropoietic Protoporphyria
- Being tested
- Dihydroxyacetone, Placebo
- Keywords
- Dihydroxyaceton, Erythropoietic protoporphyria, Light protection, Protoporphyrin IX, Self-tanning, Skin
- Medical subject headings
- Protoporphyria, Erythropoietic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydroxyacetoneOther
Application of 10% dihydroxyacetone (2 mg per square cm skin)
PlaceboOther
Application of lotion to the skin (2 mg per square cm skin)
| Study group | Role | What they receive |
|---|---|---|
| Dihydroxyacetone | Experimental | Not described Receives: Other: Dihydroxyacetone; Other: Placebo |
| Placebo | Placebo comparator | Not described Receives: Other: Dihydroxyacetone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visible light exposure dose to onset of first skin symptom
Assessed by phototesting
Measured: Meassurement one day after dihydroxyacetone application
Secondary outcomes (1)
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.
Measured: Meassurement of skin color just before dihydroxyacetone application and one day after application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start23 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythropoietic ProtoporphyriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida M. Heerfordt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780840
- Sponsor's protocol ID
- Dihydroxyacetone
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
- ClinicalTrials.gov ID
- NCT05780840
- Acronym / sponsor ID
- Dihydroxyacetone
- Conditions
- Erythropoietic Protoporphyria
- Keywords
- Dihydroxyaceton, Erythropoietic protoporphyria, Light protection, Protoporphyrin IX, Self-tanning, Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dihydroxyacetone | Experimental | Other: Dihydroxyacetone, Other: Placebo |
| Placebo | Placebo comparator | Other: Dihydroxyacetone, Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with erythropoietic protoporphyria
- At least 18 years of age
- Obtainment of written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DihydroxyacetoneApplication of 10% dihydroxyacetone (2 mg per square cm skin) | Other | Dihydroxyacetone, Placebo |
| PlaceboApplication of lotion to the skin (2 mg per square cm skin) | Other | Dihydroxyacetone, Placebo |
Primary outcome
Visible light exposure dose to onset of first skin symptom
Time frame: Meassurement one day after dihydroxyacetone application
Assessed by phototesting
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dihydroxyacetone in people with Erythropoietic Protoporphyria, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visible light exposure dose to onset of first skin symptom (time frame: Meassurement one day after dihydroxyacetone application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.