Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol

May 9, 2017 updated by: John Paoli, Vastra Gotaland Region

This pilot study will try to minimize the pain during exposure to a new red light source (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without compromising its effect on AKs.

The study design will have an open and prospective, two-armed, split-face design. Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on AK clearance rates as compared to the standard PDT irradiation protocol.

Before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. The participants will thereafter sign and date the informed consent form. This constitutes as visit 0.

On visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. The participants should have AKs on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway), which is the traditional lamp used at our department as mentioned above.

The treatment will be given at visit 1. During the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (AEs) during the hours and days after the treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. The randomization is blinded for the investigator at the FU visit to minimize the possibility of favoring one irradiation protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Dep. of Dermatology, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symmetrically distributed AKs on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands.
  • Patients >18 years of age who have signed a written informed consent.

Exclusion Criteria:

  • Pregnant or breast-feeding.
  • Participating in other clinical study at the same time or within 30 days.
  • Conditions associated with poor protocol compliance, e.g. excessive use of alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Left side first -Aktilite CL128
Randomized left side first with application of 5-aminolevulinic acid under occlusion during 3h. After that Aktilite CL128.
Device: Aktilite CL128
Infrared light, with total dose of 37J/cm2.
Drug: BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
OTHER: Right side first -Aktilite CL128
Randomized right side first with application of 5-aminolevulinic acid under occlusion during 3h. After that Aktilite CL128.
Device: Aktilite CL128
Infrared light, with total dose of 37J/cm2.
Drug: BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
OTHER: Left side first -BF-RhodoLED
Randomized left side first with application of 5-aminolevulinic acid under occlusion during 3h. After that BF-RhodoLED.
Drug: BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Device: BF-RhodoLED
Infrared light, with total dose of 37J/cm2.
OTHER: Right side first -BF-RhodoLED
Randomized right side first with application of 5-aminolevulinic acid under occlusion during 3h. After that BF-RhodoLED.
Drug: BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Device: BF-RhodoLED
Infrared light, with total dose of 37J/cm2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: Directly after PDT
Pain is assessed on a visual analog scale from 0 to 10 (0=no pain at all, 10=worst pain imaginable). The patient assesses the pain during and after the illumination phase of PDT on both treatment sides.
Directly after PDT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of PDT with the RhodoLED lamp
Time Frame: 3 months after treatment
The effectiveness of PDT on both treatment sides will be compared at follow-up after 3 months. The clinical clearance of AK lesions will be measured.
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: John Paoli, Assoc. Prof., Dep. of Dermatology, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (ESTIMATE)

December 31, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VastraGotaland

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Aktilite CL128

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe