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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00472043
Other study ID # PC T308/00
Secondary ID
Status Completed
Phase Phase 3
First received May 10, 2007
Last updated September 1, 2010
Start date October 2000
Est. completion date September 2002

Study information

Verified date September 2010
Source Galderma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.

For skin diseases, there has 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®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .

In vitro studies of animal and human tissues have 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 is to compare PDT with Metvix® cream to PDT with placebo cream in terms of patient complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle.

Secondary objectives are to compare the two treatments in terms of histological and clinical mean patient response weighted by the number of lesions within a patient, lesion response rates across patients, clinical complete patient response, cosmetic outcome and adverse events.


Description:

A patient will be randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible BCC lesions within a patient will get the same treatment. All patients will get two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression will be surgically excised. Lesions with partial response (50% or greater reduction on lesion area) will be re-treated, if they do not show complete response three months later they will be surgical excised. Lesions with complete response will be surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens will be histological examined.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

A patient with primary, nodular BCC lesion(s) suitable for entry is defined as a patient 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 patient that is ineligible for inclusion is a patient fulfilling any of the following criteria:

- Patient with porphyria.

- Patient with Gorlin's syndrome.

- Patient with Xeroderma pigmentosum

- Patients concurrently receiving immunosuppressive medication

- Patients 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.

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 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
PDT with Metvix 160 mg/g cream and Placebo cream


Locations

Country Name City State
Australia Dr. Michael Freeman Benowa Queensland
Australia Dept. of Dermatology, Royal Prince Alfred Hospital Camperdown New South Wales
Australia Department of Dermatology, St. Vincent's Hospital Melbourne Fitzroy Victoria
Australia Fremantle Dermatology Fremantle Western Australia
Australia Dermatology Dept., St. George Hospital Kogarah New South Wales
Australia Dermatology Centre Liverpool New South Wales
Australia Dermatology Dept., Princess Alexandra Hospital Woolloongabba Queensland

Sponsors (1)

Lead Sponsor Collaborator
Galderma

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely). 6 months after last treatment
Secondary Histological and clinical mean patient response rates weighted for the number of lesions within a patient 3 and 6 months after last treatment
Secondary Histological and clinical number of lesions across patients that show complete response 3 and 6 months after last treatment
Secondary Clinical complete patient response 3 and 6 months after last treatment
Secondary Evaluation of cosmetic outcome 3 and 6 months after last treatment
Secondary Adverse events 2 weeks, 4 weeks and 3 months after each treatment cycle
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