We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00469417
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 3, 2010
Information provided by:

Brief Summary:

The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of patients with primary superficial basal cell carcinoma.

Secondary objectives are to compare cosmetic outcome and tolerability (adverse events) in these patients, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.

Condition or disease Intervention/treatment Phase
Superficial Basal Cell Carcinoma Procedure: Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream Phase 3

Detailed Description:

BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, Moh's surgery, radiation, curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size, depth and localisation of the BCC lesion.

The use of PDT is attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience is promising and patients with primary BCCs will be included in this prospective, randomised, comparative, multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome.

The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy. Both on-site and independent, blinded response assessments will be analysed. The analysis based on the results of the independent review board constitutes the primary analysis.

The secondary end-points will be the proportion of patients in whom less than 75% of the BCC lesions respond completely, number of lesions across patients that show complete response, evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
Study Start Date : October 1999
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy [ Time Frame: 3 months after treatment ]

Secondary Outcome Measures :
  1. Secondary end-points: proportion of patients with less than 75% lesion complete response, number of lesions that show complete response, cosmetic outcome and adverse events. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed. [ Time Frame: Up to 60 months after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A patient with superficial BCC lesion(s) suitable for entry was defined as a patient 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 patients above 19 years of age were to be included in Austria.

Exclusion Criteria:

A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:

  • prior treatment of the BCC lesion(s)
  • patients 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
  • patient with porphyria
  • patient with Gorlin's syndrome
  • pigmented superficial BCC lesion(s)
  • morpheaform lesion(s)
  • infiltrating lesion(s)
  • 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 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.

In Amendment 1 the following exclusion criteria were added:

  • xeroderma pigmentosum lesion
  • concurrent use of immunosuppressive medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469417

University of Graz
Graz, Austria, 8036
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, B3000
Helsinki University Central Hospital
Helsinki, Finland, 00029
Hôpital Sainte-Marguerite
Marseille, France, 13277
Service de Dermatologie, C.H.U Saint Louis
Paris, France, 754747
Spedali di Brescia
Brescia, Italy, 25125
Länsjukhuset Ryhov
Jönköping, Sweden, 55185
Linköping, Sweden, 58185
Huddinge Sjukhus
Stockholm, Sweden, 14186
Regionsjukhuset i Örebro
Örebro, Sweden, 70185
United Kingdom
University of Wales
Cardiff, United Kingdom, CF4 4XN
Ninewells Hospital
Dundee, United Kingdom, DDI 954
Falkirk and District Royal Infirmary
Falkirk, United Kingdom, F1 5QE
Glasgow University Hospital
Glasgow, United Kingdom, GI2 8QQ
Sponsors and Collaborators
Principal Investigator: Nicole Basset-Séguin, Professor Saint-Louis Hospital, Paris

ClinicalTrials.gov Identifier: NCT00469417     History of Changes
Other Study ID Numbers: PC T304/99
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: September 3, 2010
Last Verified: September 2010

Keywords provided by Galderma:
Methyl aminolevulinate
Photodynamic therapy
Primary Superficial Basal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents