Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease

Last updated: February 16, 2021
Sponsor: Galderma R&D
Overall Status: Trial Not Available

Phase

N/A

Condition

Warts

Basal Cell Carcinoma

Squamous Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT00535080
CAN.15.SPR.001
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subject older than 18 years.
  • Subject presenting with:
  • Either field actinic keratoses (AKs) (mild to moderate, multiple and clusteredAKs on a severely sun-damaged skin); or
  • Biopsy-confirmed large, or multiple (several in the same anatomical area) primarysuperficial BCC lesions that are macroscopically and histologically consistentwith superficial basal cell carcinoma (sBCC) and have no histological evidence ofaggressive growth patterns; or
  • Histologically confirmed diagnosis of Bowen's disease from a biopsy taken within 3 months
  • Any subject presenting with the aforementioned lesions must not be able to be treatedoptimally by conventional therapies.
  • Female subject of childbearing potential, using an effective birth control method (seeCase Report Form) and having a negative pregnancy test at the beginning of the study,or female subject of non childbearing potential
  • Subject must be willing and capable of cooperating to the extent and degree requiredby the protocol.
  • Subject has to read Patient Information Sheet and read and sign the Informed Consentform prior to any study related procedure.

Exclusion

Exclusion Criteria:

  • A recurrent superficial BCC lesion that has previously been treated.
  • Subject whose lesions on the selected treatment zone (including a 5 cm margin aroundthe treatment area) have been treated with any of the following topical treatmentswithin the specified washout period:
  • 5-FU - 3 months
  • Cryotherapy - 3 months
  • Imiquimod - 3 months
  • PDT - 3 months
  • Diclofenac sodium - 3 months
  • Surgery, radiotherapy, curettage, electrodesiccation, retinoids, dermabrasion,laser resurfacing, salicylic acid - 3 months
  • A primary superficial BCC located close to or involving a scar of SCC
  • Subject with known porphyria.
  • Subject with target lesions on the genitals.
  • Subject with known xeroderma pigmentosum.
  • Pigmented lesion(s) on the treated area.
  • Morpheaform lesion(s) on the treated area.
  • Infiltrating lesion(s) on the treated area.
  • Female subject who is pregnant, nursing or planning a pregnancy during the study.
  • Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound orexcipients of the cream.
  • Subject who has participated in another investigational drug or device research studywithin 30 days of enrolment.

Study Design

Study Start date:
Estimated Completion Date: