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Status:

COMPLETED

Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma

Lead Sponsor:

Galderma R&D

Conditions:

Basal Cell Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than norm...

Detailed Description

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to tre...

Eligibility Criteria

Inclusion

  • Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
  • Males or females above 18 years of age.
  • Written informed consent. AND
  • Participants with high risk of surgical complications due to:
  • Anticoagulant medication or bleeding disorders
  • Cardiac risk factors
  • Anaesthetic contraindications
  • Poor surgical compliance because of participant refusal, dementia, or inability to perform wound care.
  • OR
  • • Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:
  • A large BCC lesion with the largest diameter:
  • Equal to or greater than 15 mm on extremities, except below the knees, where largest diameter should be equal to or greater than 10 mm
  • Equal to or greater than 20 mm on the trunk
  • Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone according to Swanson) or on the ear In participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.

Exclusion

  • Prior treatment of the lesion within 4 weeks.
  • A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
  • Participant with porphyria.
  • Pigmented lesions.
  • Known allergy to Metvix® or a similar compound.
  • Participation in another clinical study either concurrently or within the last 30 days
  • Participant with Gorlin's syndrome.
  • Participant with Xeroderma pigmentosum
  • Pregnant or breast-feeding (all women of child-bearing potential must document a negative pregnancy test and use contraception during the treatments and for at least one month thereafter).
  • Conditions associated with a risk of poor protocol compliance.

Key Trial Info

Start Date :

September 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2006

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT00473343

Start Date

September 1 2000

End Date

June 1 2006

Last Update

January 5 2023

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Department of Dermatology, St. George Hospital

Kogarah, New South Wales, Australia, NSW 2217

2

South East Dermatology, The Belmont Specialist Clinic

Carnia, Queensland, Australia, 4152

3

Department of Dermatology, Royal Adelaide Hospital

Adelaide, South Australia, Australia, SA 5000

4

Dermatology Department, The Queen Elisabeth Hospital

Adelaide, South Australia, Australia, SA 5011