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

Last updated: February 28, 2024
Sponsor: Galderma R&D
Overall Status: Completed

Phase

3

Condition

Warts

Cancer/tumors

Basal Cell Carcinoma

Treatment

Placebo Cream

Metvix cream

Photodynamic Therapy (PDT)

Clinical Study ID

NCT00472108
PC T307/00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 30days.

  • Pregnant or breast-feeding: All women of child-bearing potential must use adequatecontraception (e.g. barrier methods, oral contraceptives or intrauterine device)during the treatment period and one month thereafter. In addition, they must have anegative 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 largerthan 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

Total Participants: 65
Treatment Group(s): 3
Primary Treatment: Placebo Cream
Phase: 3
Study Start date:
December 01, 2000
Estimated Completion Date:
April 30, 2002

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.

Connect with a study center

  • Clinical Research Specialists Inc

    Santa Monica, California 90404-2115
    United States

    Site Not Available

  • Department of Dermatology, University of Minnesota Hospital and Clinic

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Department of Dermatology, Mayo Medical School, Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Academic Dermatology Associates

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Department of Dermatology, Roswell Park Cancer Institue

    Buffalo, New York 14263
    United States

    Site Not Available

  • Northwest Cutaneous Research Specialists

    Portland, Oregon 97210
    United States

    Site Not Available

  • DermResearch, Inc.

    Austin, Texas 78759
    United States

    Site Not Available

  • Texas Dermatology Research Institute

    Dallas, Texas 75230
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 230507
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.