Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified January 2024 by Galderma R&D
Sponsor
Galderma R&D
Information Provided by (Responsible Party)
Galderma R&D
Clinicaltrials.gov Identifier
NCT00472108
Other Study ID Numbers:
PC T307/00
First Submitted
May 9, 2007
First Posted
May 10, 2007
Results First Posted
February 20, 2022
Last Update Posted
August 4, 2024
Last Verified
January 2024

ClinicalTrials.gov processed this data on February 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

A participants were randomised to PDT with Metvix cream or PDT with placebo cream. All eligible basal cell carcinoma (BCC) lesions within a participant received same treatment. All participants received two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression were surgically excised. Lesions with partial response 50 percent (%) or greater reduction on lesion area) were re-treated; if they do not show complete response three months later, they were surgically excised. Lesions with complete response were surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens were histologically examined.

Condition or DiseaseIntervention/Treatment
Basal Cell Carcinoma
Radiation: Photodynamic Therapy (PDT)Radiation: Photodynamic Therapy (PDT)

Study Design

Study TypeInterventional
Actual Enrollment65 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
Study Start DateNovember 30, 2000
Actual Primary Completion DateMarch 31, 2002
Actual Study Completion DateMarch 31, 2002

Groups and Cohorts

Group/CohortIntervention/Treatment
Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g)
Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
Radiation: Photodynamic Therapy (PDT)
Placebo Cream
Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm\*2 and fluency rate of 50-200 mW/cm\*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.
Radiation: Photodynamic Therapy (PDT)

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Histologically Confirmed Complete Response
    The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
Secondary Outcome Measures
  1. Percentage of Lesions With Histologically Confirmed Complete Lesion Response
    Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed complete lesion response were reported.
  2. Percentage of Lesions With Clinically Confirmed Complete Lesion Response
    Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. The clinically confirmed complete lesion response were reported.
  3. Histological Verified Lesions With Complete Response
    Histological confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of histologically confirmed lesions with complete response were reported.
  4. Clinically Verified Lesions With Complete Response
    Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of clinically confirmed lesions with complete response were reported.
  5. Number of Participants With Clinically Evaluated Complete Response
    The on-site investigator evaluated the lesion response by comparing to the lesion size before and after treatment. Complete response here means complete disappearance of a lesion. Number of participants for whom one or more lesions had a complete response were reported.
  6. Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
    Cosmetic outcomes were assessed with regards to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. Cosmetic outcome were graded as excellent, good, fair or poor where: excellent: no scarring, atrophy or induration, no or slight occurrence of redness or change in pigmentation compared to adjacent skin; good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin; fair: slight to moderate occurrence of scarring, atrophy or induration and Poor: extensive occurrence of scarring, atrophy or induration. The investigator and participants assessed the cosmetic outcome for each lesion has responded completely. Participants were asked to evaluate evaluate the cosmetic outcome according to the same categories: excellent, good, fair cosmetic outcome. Number of participants with summarized cosmetic outcomes for all symptoms as assessed by Investigator and participants were reported.
  7. Number of Participants With Adverse Events and Serious Adverse Events (AEs)
    Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with AEs and serious AEs were reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
Clinically diagnosed primary nodular BCC lesion(s).
Histologically confirmed diagnosis of BCC.
BCC lesions suitable for simple excision surgery.
Males or females above 18 years of age.
Written informed consent.
Exclusion Criteria
A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
Participants with porphyria.
Participants with Gorlin's syndrome.
Participants with Xeroderma pigmentosum.
Participants concurrently receiving immunosuppressive medication.
Participants with a history of arsenic exposure.
Participants with BCC arising in a previous radiated area.
Known allergy to Metvix, a similar PDT 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 use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment..
Conditions associated with a risk of poor protocol compliance. Lesion Exclusion Criteria:
A nodular BCC lesion in periorbital area, ears and nasolabial fold.
A nodular BCC lesion with the longest diameter less than 6 millimeter (mm) or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
Pigmented nodular BCC lesion(s)
Morpheaform nodular BCC lesion(s).
Infiltrating nodular BCC lesion(s).
Prior treatment of the BCC lesion(s).

Contacts and Locations

Sponsors and CollaboratorsGalderma R&D
Locations
Clinical Research Specialists Inc | Santa Monica California, United States, 90404-2115Department of Dermatology, University of Minnesota Hospital and Clinic | Minneapolis Minnesota, United States, 55455Department of Dermatology, Mayo Medical School, Mayo Clinic | Rochester Minnesota, United States, 55905Academic Dermatology Associates | Albuquerque New Mexico, United States, 87106Department of Dermatology, Roswell Park Cancer Institue | Buffalo New York, United States, 14263Northwest Cutaneous Research Specialists | Portland Oregon, United States, 97210DermResearch, Inc. | Austin Texas, United States, 78759Texas Dermatology Research Institute | Dallas Texas, United States, 75230Virginia Clinical Research, Inc. | Norfolk Virginia, United States, 230507
Investigators
Principal Investigator: Whitney Tope, MPhil, MD, University of Minnesota Hospital and Clinic