Clinical trial NCT00472108: Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
Official title: A 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Basal Cell Carcinoma
Keywords: Nodular Basal Cell Carcinoma
Basal Cell Carcinoma
PDT with Metvix 160 mg/g cream
PDT with placebo cream
Histological verification
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-05-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination.

For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity.

In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation.

The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Histologically Confirmed Complete Response
timeFrame: up to 9 months
Secondary outcomes:
measure: Percentage of Lesions With Histologically Confirmed Complete Lesion Response
timeFrame: up to 9 months
measure: Percentage of Lesions With Clinically Confirmed Complete Lesion Response
timeFrame: up to 9 months
measure: Histological Verified Lesions With Complete Response
timeFrame: up to 9 months
measure: Clinically Verified Lesions With Complete Response
timeFrame: up to 9 months
measure: Number of Participants With Clinically Evaluated Complete Response
timeFrame: up to 9 months
measure: Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
timeFrame: up to 9 months
measure: Number of Participants With Adverse Events and Serious Adverse Events (AEs)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Clinical Research Specialists Inc
state: California
city: Minneapolis
country: United States
facility: Department of Dermatology, University of Minnesota Hospital and Clinic
state: Minnesota
city: Rochester
country: United States
facility: Department of Dermatology, Mayo Medical School, Mayo Clinic
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Buffalo
country: United States
facility: Department of Dermatology, Roswell Park Cancer Institue
state: New York
city: Portland
country: United States
facility: Northwest Cutaneous Research Specialists
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Texas Dermatology Research Institute
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: University of Minnesota Hospital and Clinic
name: Whitney Tope, MPhil, MD
role: PRINCIPAL_INVESTIGATOR
References: