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Prophylactic Photodynamic Therapy to Organ Transplant Patients

NCT ID: NCT00365521

Last Updated: 2008-06-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ transplanted recipients.

Detailed Description

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Conditions

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Organ Transplants

Keywords

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Organ transplant patients receiving immunosuppressive therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Interventions

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Photodynamic Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Organ transplant recipients.
* Age 40 years or older.

Exclusion Criteria

* Patients younger than 40 years and older than 70 years.
* Clinical signs of skin cancer, actinic keratoses or warts at the time of inclusion.
* Previous photodynamic therapy to the skin areas investigated.
* Pregnancy or breast feeding patients.
* Patients with porphyria.
* Patients with a tendency to produce hypertrophic scars or keloids.
* Patients with known allergy to Metvix.
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients etc.).
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Merete Hædersdal, MD, PhD, DrMedSci

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Merete Hædersdal, MD, PhD, DrMedSci

Role: CONTACT

Phone: +45 35316002

Email: [email protected]

Facility Contacts

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Merete Hædersdal

Role: primary

Other Identifiers

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KF-01-314759

Identifier Type: -

Identifier Source: org_study_id