NCT00432224

Brief Summary

The objective of the study is to evaluate the use of sunlight instead of red light during photodynamic therapy of actinic keratoses using methyl aminolevulinate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
Last Updated

February 7, 2007

Status Verified

February 1, 2007

First QC Date

February 6, 2007

Last Update Submit

February 6, 2007

Conditions

Actinic Keratoses

Interventions

photodynamic therapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • symmetric actinic keratoses in scalp or face

You may not qualify if:

  • porphyria, pregnancy, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Hans Christian Wulf, Professor, MD

    Bispebjerg Hospital

    STUDY DIRECTOR

  • Merete Hædersdal, MD, PhD

    Bispebjerg Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 7, 2007

Study Start

May 1, 2006

Study Completion

February 1, 2007

Last Updated

February 7, 2007

Record last verified: 2007-02

Locations

DK(1)