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

NCT ID: NCT03697590

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Keratosis, Actinic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PDT with no curettage

Group Type EXPERIMENTAL

No curettage

Intervention Type DRUG

Standard PDT without curettage

Standard PDT

Group Type ACTIVE_COMPARATOR

Curettage

Intervention Type DRUG

Standard PDT

Interventions

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No curettage

Standard PDT without curettage

Intervention Type DRUG

Curettage

Standard PDT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Multiple actinic keratosis on the forehead or scalp

Exclusion Criteria

* Known allergy to methyl aminolevulinate
* Porphyria
* Pregnancy
* Lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ida M. Heerfordt

Principal investigator, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg Hospital

Copenhagen NV, DK, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PDT with and without curettage

Identifier Type: -

Identifier Source: org_study_id

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