Skip to main content
Clinical Trials/NCT02372370
NCT02372370CompletedPhase 1

Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)

Bispebjerg Hospital0 sites12 target enrollmentStarted: December 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Active Comparator

All participants receive all interventions.

Intervention: Microneedle pretreatment + MAL-PDT (Procedure)

Interventions

Active Comparator

All participants receive all interventions.

Intervention: Sandpaper pretreatment + MAL-PDT (Procedure)

Interventions

Active Comparator

All participants receive all interventions.

Intervention: Curettage pretreatment + MAL-PDT (Procedure)

Interventions

Active Comparator

All participants receive all interventions.

Intervention: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT (Procedure)

Interventions

Active Comparator

All participants receive all interventions.

Intervention: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT (Procedure)

Interventions

Active Comparator

All participants receive all interventions.

Intervention: MAL Control. (Drug)

Interventions

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merete Haedersdal

Professor, DMSci, MD

Bispebjerg Hospital

Similar Trials