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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697590
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ida M. Heerfordt, Bispebjerg Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Keratosis, Actinic Drug: No curettage Drug: Curettage Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: PDT with no curettage Drug: No curettage
Standard PDT without curettage
Active Comparator: Standard PDT Drug: Curettage
Standard PDT


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria:

  • Known allergy to methyl aminolevulinate
  • Porphyria
  • Pregnancy
  • Lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697590


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, DK, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
More Information
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Responsible Party: Ida M. Heerfordt, Principal investigator, MD, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03697590    
Other Study ID Numbers: PDT with and without curettage
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms