NCT00711178

Brief Summary

A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix in patients with multiple actinic keratosis on the face and/or scalp.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 2, 2010

Status Verified

March 1, 2008

Enrollment Period

7 months

First QC Date

July 7, 2008

Last Update Submit

November 1, 2010

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

  • response rate

    3 months

Study Arms (2)

A

ACTIVE COMPARATOR

2 hours sunlight

Procedure: Photodynamic therapy with methyl aminolevulinate

B

ACTIVE COMPARATOR

3 hours of sunlight

Procedure: Photodynamic therapy with methyl aminolevulinate

Interventions

Photodynamic therapy with methyl aminolevulinatePROCEDURE

daylight mediated photodynamic therapy

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older, 5 AK in face and scalp

You may not qualify if:

  • immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapymethyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Hans Christian Wulf, Professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 8, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 2, 2010

Record last verified: 2008-03

Locations

DK(1)