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Pretreatments of the Skin Prior to PDT

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ClinicalTrials.gov Identifier: NCT02372370
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merete Haedersdal, 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).

Condition or disease Intervention/treatment Phase
Healthy 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 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: Interventions
All participants receive all 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain [ Time Frame: Day 0 ]
    Pain during treatment as measured by Visual Analog Scale.

  2. Skin reactions [ Time Frame: Day 0, Day 1, Day 3, Day 7 ]
    Skin reactions evaluated on a clinical scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Tattoos, moles or scars in treatment area
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merete Haedersdal, Professor, DMSci, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02372370    
Other Study ID Numbers: H-3-2014-132
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015