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

NCT00472108 | Completed Phase 3 Results

• 1 other identifier: PC T307/00
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (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.

  up to 9 months

Secondary Outcomes (7)

• Percentage of Lesions With Histologically Confirmed Complete Lesion Response

  up to 9 months

• Percentage of Lesions With Clinically Confirmed Complete Lesion Response

  up to 9 months

• Histological Verified Lesions With Complete Response

  up to 9 months

• Clinically Verified Lesions With Complete Response

  up to 9 months

• Number of Participants With Clinically Evaluated Complete Response

  up to 9 months

Study Arms (2)

Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g)

EXPERIMENTAL

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); Drug: Metvix cream

Placebo Cream

PLACEBO COMPARATOR

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); Drug: Placebo Cream

Interventions

Photodynamic Therapy (PDT) RADIATION

Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g); Placebo Cream

Metvix cream DRUG

Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g)

Placebo Cream DRUG

Placebo Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (9)

Clinical Research Specialists Inc

Santa Monica, California, 90404-2115, United States

Location

Department of Dermatology, University of Minnesota Hospital and Clinic

Minneapolis, Minnesota, 55455, United States

Location

Department of Dermatology, Mayo Medical School, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Department of Dermatology, Roswell Park Cancer Institue

Buffalo, New York, 14263, United States

Location

Northwest Cutaneous Research Specialists

Portland, Oregon, 97210, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Texas Dermatology Research Institute

Dallas, Texas, 75230, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 230507, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: CTA Coordinator
• Organization: Galderma R&D SNC

cta.coordinator@galderma.com

+33 493 95 70 85

Study Officials

• Whitney Tope, MPhil, MD

  University of Minnesota Hospital and Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: December 1, 2000
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Locations

US (9)