PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma

NCT00472043 | Completed Phase 3 Results

• 1 other identifier: PC T308/00
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

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 had 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 levels of photoactive porphyrins 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 participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives were 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; Photodynamic therapy (PDT); Metvix; Histological verification; PDT with Metvix cream; PDT with Placebo cream

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Histologically Confirmed Complete Response (CR)

  Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) 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 disappearance of lesion. Percentage of participants with histologically confirmed complete response were reported.

  up to 6 months

Secondary Outcomes (6)

• Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response

  Up to 3 months

• Histological Lesion Response

  Up to 3 months

• Percentage of Participants With Clinically Confirmed Participant Complete Response (CR)

  Up to 9 months

• Cosmetic Outcomes for Lesions Assessed by Investigator

  Up to 3 months

• Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation

  Up to 6 months

Study Arms (2)

Metvix® cream 160 milligram per gram

EXPERIMENTAL

Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2.

Drug: PDT with Metvix 160 mg/g cream

Placebo

PLACEBO COMPARATOR

Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2.

Drug: Placebo

Interventions

PDT with Metvix 160 mg/g cream DRUG

Metvix® cream 160 milligram per gram

Placebo DRUG

Placebo

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.
• Participant with Gorlin's syndrome.
• Participant with Xeroderma pigmentosum.
• Participants concurrently receiving immunosuppressive medication.
• Participants with a history of arsenic exposure.
• 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 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).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (7)

Dept. of Dermatology, Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Dermatology Dept., St. George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Dermatology Centre

Liverpool, New South Wales, 2170, Australia

Location

Dr. Michael Freeman

Benowa, Queensland, 4217, Australia

Location

Dermatology Dept., Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Department of Dermatology, St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

1-phenyl-3,3-dimethyltriazene; methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Peter Foley, MD

  Department of Dermatology, St. Vincent's Hospital Melbourne

  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

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: October 1, 2000
• Primary Completion: September 30, 2002
• Study Completion: September 30, 2002
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-02

Locations

AU (7)