Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 12
- Primary Endpoint
- Protoporphyrin IX (PpIX) fluorescence
Study Overview
Brief 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).
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older, healthy, fair skinned (skin type I-III)
Exclusion Criteria
- •Pregnant women
- •Tattoos, moles or scars in treatment area
Arms & Interventions
Interventions
All participants receive all interventions.
Intervention: Microneedle pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
Intervention: Sandpaper pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
Intervention: Curettage pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
Intervention: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
Intervention: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
Intervention: MAL Control. (Drug)
Interventions
All participants receive all interventions.
Intervention: Untreated Control (Other)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Pain(Day 0)
- Skin reactions(Day 0, Day 1, Day 3, Day 7)
Investigators
Merete Haedersdal
Professor, DMSci, MD
Bispebjerg Hospital