Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage

October 5, 2018 updated by: Ida M. Heerfordt, Bispebjerg Hospital
Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

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

  • Denmark
    • DK
      • Copenhagen NV, DK, Denmark, 2400
        • Bispebjerg 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:

- Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria:

  • Known allergy to methyl aminolevulinate
  • Porphyria
  • Pregnancy
  • Lactation

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PDT with no curettage
Drug: No curettage
Standard PDT without curettage
Active Comparator: Standard PDT
Drug: Curettage
Standard PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete lesion response rate
Time Frame: Treatment efficacy was evaluated 3 months after PDT
Complete lesion response rate, was defined as the number of completely responding lesions divided by the total number of treated lesion in each field. Complete lesion response was defined as complete disappearance of the lesion both by palpation and visually.
Treatment efficacy was evaluated 3 months after PDT

Collaborators and Investigators

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

Sponsor

Bispebjerg 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 (Actual)

June 1, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDT with and without curettage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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