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/AClinical Study ID
NCT00535080
CAN.15.SPR.001
Ages > 18 All Genders
Study Summary
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: