Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.

Metvix® cream

Carl Vinciullo, MD

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 photoactive porphyrins. 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 .

BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.

In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.

The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).

The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).

Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma

An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma

Patient 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.

Complete response was defined as no clinically visible BCC lesions in the treatment area.

Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:

* excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin
* good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin
* fair: slight to moderate occurrence of scarring, atrophy or induration
* poor: extensive occurrence of scarring, atrophy or induration.

Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as:

excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.

Recurrence rate in complete clearance(CC) group was analyzed.

Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:

excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.

Galderma R&D

Metvix® PDT

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment.

Clinical Operations

Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle

Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle

Investigator: Excellent

Investigator: Good

Investigator: Fair

Investigator: Not applicable

Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle

Participants: Excellent

Participants: Good

Participants: Fair

Participants: Not applicable

Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle

12 months

24 months

36 months

48 months

60 months

Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. "Number analyzed", signifies those participants who were evaluable for this outcome measure at the specified time point.

Recurrence Rate in Complete Clearance Group

Excellent: At 24 month

Good: At 24 month

Fair: At 24 month

Poor: At 24 month

Excellent: At 36 month

Good: At 36 month

Fair: At 36 month

Excellent: At 60 month

Good: At 60 month

Fair: At 60 month

Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma	NCT00473343	Basal Cell Carc...	Metvix® cream	18 Years -	Galderma R&D
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma	NCT00473343	Basal Cell Carc...	Metvix® cream	18 Years -	Galderma R&D

Spots Global Cancer Trial Database for histologically confirmed complete response