Pretreatments of the Skin Prior to PDT

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Healthy
Interventions
PROCEDURE

Microneedle 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.

PROCEDURE

Sandpaper 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.

PROCEDURE

Curettage 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.

PROCEDURE

Ablative 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.

PROCEDURE

Non-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.

DRUG

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)).

OTHER

Untreated Control

Untreated control. No interventions.

All Listed Sponsors
lead

Bispebjerg Hospital

OTHER

NCT02372370 - Pretreatments of the Skin Prior to PDT | Biotech Hunter | Biotech Hunter