Know Cancer

or
forgot password

A Multicentre, Randomised Study of Photodynamic Therapy(PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis, Warts, Basal Cell Carcinoma, Bowens Disease, Squamous Cell Carcinoma

Thank you

Trial Information

A Multicentre, Randomised Study of Photodynamic Therapy(PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer


The treatment area (5x10 cm2) will be treated at baseline and at 3, 9 and 15 months visits.
At baseline the area will be treated with fractionated Metvix® PDT treatment consisting of
two treatment one week apart and at 3, 9, and 15 months visits with single Metvix® PDT
treatment. The patients will be evaluated for occurrence of new lesions, lesion response and
recurrence at 3 (not recurrence), 9, 15, 21 and 27 months visits. New and recurrent lesions
in the treated area will be treated with Metvix® PDT treatment. Lesions with partial
response in the treated area will be re-treated with Metvix® PDT and lesions with no
response will be treated with lesion specific treatment at the discretion of the
investigator.

In the contralateral control area (5x10 cm2), new and recurrent lesions and lesions in
non-complete response will be treated with lesion specific treatment at the discretion of
the investigator at each study visit.


Inclusion Criteria:



- Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10
skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral
areas (diameter 5x10 cm) in the face, the scalp, the extremities or on the
trunk/neck.

- Transplant recipients who previously are treated more than once for their skin
lesions.

- Transplant recipients who have received immunosuppressive therapy for more than 3
years.

- Males or females above 18 years of age.

- Written informed consent.

Exclusion Criteria:

- Patients with more than 10 skin lesions (AK,BCC,SCC in situ,warts) in one of the two
areas.

- Patient with SCC (not SCC in situ) in one of the two areas.

- Patients not previously treated or treated only once for their skin lesions.

- Patient with rosacea in one of the two areas.

- Patients with morpheaform/highly infiltrating BCC

- Known allergy to methyl-aminolevulinate, a similar compound or excipients of the
cream

- Participation in other clinical studies either concurrently or within the last 30
days.

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative pregnancy test and use the pill or IUD during the treatments and for at
least one month thereafter).

- Conditions associated with a risk of poor protocol compliance

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To Compare occurrence of new lesions (AK, BCC, SCC and warts) in the treated area with the contralateral control area (symmetrically).

Outcome Time Frame:

3, 9, 15, 21 and 27 months after first treatment

Principal Investigator

Ann-Marie Wennberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sahlgrenska University Hospital, Gothenburg, Sweden

Authority:

Sweden: Medical Products Agency

Study ID:

PC T313/03

NCT ID:

NCT00472459

Start Date:

July 2003

Completion Date:

July 2006

Related Keywords:

  • Actinic Keratosis
  • Warts
  • Basal Cell Carcinoma
  • Bowens Disease
  • Squamous Cell Carcinoma
  • Non-melanoma skin cancer
  • Organ transplant recipients
  • Photodynamic therapy
  • Actinic keratosis
  • Bowen's Disease
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Keratosis
  • Keratosis, Actinic
  • Carcinoma, Basosquamous

Name

Location