HealthyPhase 1NCT02372370
Pretreatments of the Skin Prior to PDT
A Phase 1 study testing Microneedle pretreatment + MAL-PDT, Sandpaper pretreatment + MAL-PDT and Curettage pretreatment + MAL-PDT in people with Healthy, run by Bispebjerg Hospital.
Trial summary
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Microneedle pretreatment + MAL-PDT, Sandpaper pretreatment + MAL-PDT and Curettage pretreatment + MAL-PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2014
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, healthy, fair skinned (skin type I-III)
Who cannot join
- Pregnant women
- Tattoos, moles or scars in treatment area
About this study
Official title: Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).
Read the detailed description
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence.
Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.
- Conditions
- Healthy
- Being tested
- Microneedle pretreatment + MAL-PDT, Sandpaper pretreatment + MAL-PDT, Curettage pretreatment + MAL-PDT, Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT, Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle pretreatment + MAL-PDTProcedure or surgery
Interventions: microneedling of the skin using dermarollers prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
Sandpaper pretreatment + MAL-PDTProcedure or surgery
Interventions: abrasion of the skin using Abrasive Pads for Skin Preparation prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
Curettage pretreatment + MAL-PDTProcedure or surgery
Interventions: curettage of the skin using a curette prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
Ablative Fractional Laser (AFXL) pretreatment + MAL-PDTProcedure or surgery
Interventions: Ablative Fractional Laser (AFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDTProcedure or surgery
Interventions: Non-Ablative Fractional Laser (NAFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
MAL Control.Drug
Intervention: Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).
Untreated ControlOther
Untreated control. No interventions.
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Active comparator | All participants receive all interventions. Receives: Procedure: Microneedle pretreatment + MAL-PDT; Procedure: Sandpaper pretreatment + MAL-PDT; Procedure: Curettage pretreatment + MAL-PDT; Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT; Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT; Drug: MAL Control.; Other: Untreated Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protoporphyrin IX (PpIX) fluorescence
Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden).
Measured: Day 0
Secondary outcomes (2)
Pain
Pain during treatment as measured by Visual Analog Scale.
Measured: Day 0
Skin reactions
Skin reactions evaluated on a clinical scale.
Measured: Day 0, Day 1, Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372370
- Sponsor's protocol ID
- H-3-2014-132
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bay C, Lerche CM, Ferrick B, Philipsen PA, Togsverd-Bo K, Haedersdal M. Comparison of Physical Pretreatment Regimens to Enhance Protoporphyrin IX Uptake in Photodynamic Therapy: A Randomized Clinical Trial. JAMA Dermatol. 2017 Apr 1;153(4):270-278. doi: 10.1001/jamadermatol.2016.5268.
PubMed 28146245
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)
- ClinicalTrials.gov ID
- NCT02372370
- Acronym / sponsor ID
- H-3-2014-132
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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.
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).
Detailed description
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence.
Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | Active comparator | Procedure: Microneedle pretreatment + MAL-PDT, Procedure: Sandpaper pretreatment + MAL-PDT, Procedure: Curettage pretreatment + MAL-PDT, Procedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT, Procedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT, Drug: MAL Control., Other: Untreated ControlAll participants receive all interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, healthy, fair skinned (skin type I-III)
Key exclusion criteria (2 listed)
- Pregnant women
- Tattoos, moles or scars in treatment area
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 |
|---|---|---|
| Microneedle pretreatment + MAL-PDTInterventions: microneedling of the skin using dermarollers prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong. | Procedure or surgery | Interventions |
| Sandpaper pretreatment + MAL-PDTInterventions: abrasion of the skin using Abrasive Pads for Skin Preparation prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong. | Procedure or surgery | Interventions |
| Curettage pretreatment + MAL-PDTInterventions: curettage of the skin using a curette prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong. | Procedure or surgery | Interventions |
| Ablative Fractional Laser (AFXL) pretreatment + MAL-PDTInterventions: Ablative Fractional Laser (AFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong. | Procedure or surgery | Interventions |
| Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDTInterventions: Non-Ablative Fractional Laser (NAFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong. | Procedure or surgery | Interventions |
| MAL Control.Intervention: Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). | Drug | Interventions |
| Untreated ControlUntreated control. No interventions. | Other | Interventions |
Primary outcome
Protoporphyrin IX (PpIX) fluorescence
Time frame: Day 0
Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden).
2 secondary outcomes
Pain
Time frame: Day 0
Skin reactions
Time frame: Day 0, Day 1, Day 3, Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Derived from this study: PubMed 28146245Bay C, Lerche CM, Ferrick B, Philipsen PA, Togsverd-Bo K, Haedersdal M. Comparison of Physical Pretreatment Regimens to Enhance Protoporphyrin IX Uptake in Photodynamic Therapy: A Randomized Clinical Trial. JAMA Dermatol. 2017 Apr 1;153(4):270-278. doi: 10.1001/jamadermatol.2016.5268.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microneedle pretreatment + MAL-PDT, Sandpaper pretreatment + MAL-PDT and Curettage pretreatment + MAL-PDT in people with Healthy, run by Bispebjerg Hospital.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protoporphyrin IX (PpIX) fluorescence (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02372370, which also lists 1 linked publication.
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 26 Feb 2015.