Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma

NCT00469417 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PC T304/99
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 14

Brief Summary

The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.

Conditions

Superficial Basal Cell Carcinoma

Keywords

Methyl aminolevulinate; Photodynamic therapy; Primary Superficial Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months

Secondary Outcomes (5)

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

  3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months

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

  3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months)

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

  3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months)

• Recurrence Rate in Complete Clearance Group

  12, 24, 36, 48 and 60 months after last Metvix PDT cycle or Cryotherapy (Up to 5 years)

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

  24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years)

Study Arms (2)

Metvix® PDT

EXPERIMENTAL

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.

Drug: Metvix® cream

Cryotherapy

ACTIVE COMPARATOR

Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks.

Procedure: Hand held liquid nitrogen spray cryotherapy

Interventions

Metvix® cream DRUG

Also known as: Methyl 5-aminolevulinate hydrochloride

Metvix® PDT

Hand held liquid nitrogen spray cryotherapy PROCEDURE

Cryotherapy

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 superficial BCC lesion(s) suitable for entry was defined as a participant with:
• histologically confirmed diagnosis of primary superficial BCC lesion(s)
• BCC lesions suitable for cryotherapy
• males or females above 18 years of age
• written informed consent. In accordance with Amendment 2 (local amendment), only participant above 19 years of age were to be included in Austria.

You may not qualify if:

• prior treatment of the BCC lesion(s)
• participant with more than 10 eligible BCC lesions
• a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
• a superficial BCC lesion with the largest diameter smaller than 6 mm
• participant with porphyria
• participant with Gorlin's syndrome
• pigmented superficial BCC lesion(s)
• morpheaform lesion(s)
• infiltrating lesion(s)
• 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 had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
• conditions associated with a risk of poor protocol compliance.
• xeroderma pigmentosum lesion

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (14)

University of Graz

Graz, 8036, Austria

Location

Universitaire Ziekenhuizen Leuven

Leuven, B3000, Belgium

Location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Hôpital Sainte-Marguerite

Marseille, 13277, France

Location

Service de Dermatologie, C.H.U Saint Louis

Paris, 754747, France

Location

Spedali di Brescia

Brescia, 25125, Italy

Location

Länsjukhuset Ryhov

Jönköping, 55185, Sweden

Location

Universitetssjukhuset

Linköping, 58185, Sweden

Location

Regionsjukhuset i Örebro

Örebro, 70185, Sweden

Location

Huddinge Sjukhus

Stockholm, 14186, Sweden

Location

University of Wales

Cardiff, CF4 4XN, United Kingdom

Location

Ninewells Hospital

Dundee, DDI 954, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, F1 5QE, United Kingdom

Location

Glasgow University Hospital

Glasgow, GI2 8QQ, United Kingdom

Location

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Nicole Basset-Séguin, Professor

  Saint-Louis Hospital, Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: October 18, 1999
• Primary Completion: September 5, 2001
• Study Completion: April 1, 2005
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Locations

BE (1); FI (1); AU (1); FR (2); IT (1); SE (4); GB (4)