Healthy
Conditions
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.
Interventions
PROCEDUREMicroneedle pretreatment + MAL-PDT
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.
PROCEDURESandpaper pretreatment + MAL-PDT
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.
PROCEDURECurettage pretreatment + MAL-PDT
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.
PROCEDUREAblative Fractional Laser (AFXL) pretreatment + MAL-PDT
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.
PROCEDURENon-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT
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.
DRUGMAL 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)).
OTHERUntreated Control
Untreated control. No interventions.
Sponsors
Bispebjerg Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protoporphyrin IX (PpIX) fluorescence | Day 0 | Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Day 0 | Pain during treatment as measured by Visual Analog Scale. |
| Skin reactions | Day 0, Day 1, Day 3, Day 7 | Skin reactions evaluated on a clinical scale. |
Outcome results
None listed