Back to resultsPhotodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
Primary Purpose
Keratosis, Actinic
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
No curettage
Curettage
Sponsored by
About this trial
This is an interventional treatment trial for Keratosis, Actinic
Eligibility Criteria
Inclusion Criteria:
- Multiple actinic keratosis on the forehead or scalp
Exclusion Criteria:
- Known allergy to methyl aminolevulinate
- Porphyria
- Pregnancy
- Lactation
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PDT with no curettage
Standard PDT
Arm Description
Outcomes
Primary Outcome Measures
Complete lesion response rate
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03697590
Brief Title
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
Official Title
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDT with no curettage
Arm Type
Experimental
Arm Title
Standard PDT
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
No curettage
Intervention Description
Standard PDT without curettage
Intervention Type
Drug
Intervention Name(s)
Curettage
Intervention Description
Standard PDT
Primary Outcome Measure Information:
Title
Complete lesion response rate
Description
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.
Time Frame
Treatment efficacy was evaluated 3 months after PDT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Multiple actinic keratosis on the forehead or scalp
Exclusion Criteria:
Known allergy to methyl aminolevulinate
Porphyria
Pregnancy
Lactation
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
State/Province
DK
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
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