NCT02372370

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

Same day

First QC Date

February 10, 2015

Last Update Submit

February 20, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Protoporphyrin IX (PpIX) fluorescence

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

    Day 0

Secondary Outcomes (2)

  • Pain

    Day 0

  • Skin reactions

    Day 0, Day 1, Day 3, Day 7

Study Arms (1)

Interventions

ACTIVE COMPARATOR

All participants receive all interventions.

Procedure: Microneedle pretreatment + MAL-PDTProcedure: Sandpaper pretreatment + MAL-PDTProcedure: Curettage pretreatment + MAL-PDTProcedure: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDTProcedure: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDTDrug: MAL Control.Other: Untreated Control

Interventions

Microneedle pretreatment + MAL-PDTPROCEDURE

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.

Interventions
Sandpaper pretreatment + MAL-PDTPROCEDURE

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.

Interventions
Curettage pretreatment + MAL-PDTPROCEDURE

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.

Interventions
Ablative Fractional Laser (AFXL) pretreatment + MAL-PDTPROCEDURE

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.

Interventions
Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDTPROCEDURE

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.

Interventions
MAL Control.DRUG

Intervention: Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).

Interventions
Untreated ControlOTHER

Untreated control. No interventions.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bay C, Lerche CM, Ferrick B, Philipsen PA, Togsverd-Bo K, Haedersdal M. Comparison of Physical Pretreatment Regimens to Enhance Protoporphyrin IX Uptake in Photodynamic Therapy: A Randomized Clinical Trial. JAMA Dermatol. 2017 Apr 1;153(4):270-278. doi: 10.1001/jamadermatol.2016.5268.

    PMID: 28146245DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSci, MD

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 26, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 26, 2015

Record last verified: 2015-02