Pretreatments of the Skin Prior to PDT

Phase 1

Completed

• Conditions: Healthy
• Interventions: 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

• Registration Number: NCT02372370
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 18 years or older, healthy, fair skinned (skin type I-III)

Exclusion Criteria

• Pregnant women
• Tattoos, moles or scars in treatment area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventions	Sandpaper pretreatment + MAL-PDT	All participants receive all interventions.
Interventions	Untreated Control	All participants receive all interventions.
Interventions	Curettage pretreatment + MAL-PDT	All participants receive all interventions.
Interventions	MAL Control.	All participants receive all interventions.
Interventions	Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT	All participants receive all interventions.
Interventions	Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT	All participants receive all interventions.
Interventions	Microneedle pretreatment + MAL-PDT	All participants receive all interventions.

Primary Outcome Measures

Name	Time	Method
Protoporphyrin IX (PpIX) fluorescence	Day 0	Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden).

Secondary Outcome Measures

Name	Time	Method
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.