Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedOctober 9, 2018
June 1, 2017
7 months
October 4, 2018
October 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Treatment efficacy was evaluated 3 months after PDT
Study Arms (2)
PDT with no curettage
EXPERIMENTALStandard PDT
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- Multiple actinic keratosis on the forehead or scalp
You may not qualify if:
- Known allergy to methyl aminolevulinate
- Porphyria
- Pregnancy
- Lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen NV, DK, 2400, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, MD, PhD
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 5, 2018
Study Start
June 1, 2017
Primary Completion
December 20, 2017
Study Completion
December 20, 2017
Last Updated
October 9, 2018
Record last verified: 2017-06