Superficial Basal Cell CarcinomaPhase 3NCT00469417
Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
A Phase 3 study testing Metvix® cream and Hand held liquid nitrogen spray cryotherapy in people with Superficial Basal Cell Carcinoma, run by Galderma R&D at 14 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- Metvix® cream and Hand held liquid nitrogen spray cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 18 Oct 1999to Apr 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A participant or lesion fulfilling any of the following criteria was ineligible for inclusion:
- 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
Show all 18Show fewer
- 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.
- In Amendment 1 the following exclusion criteria were added:
- xeroderma pigmentosum lesion
- concurrent use of immunosuppressive medication.
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Sweden4 sites
Länsjukhuset Ryhov
Jönköping, 55185
Universitetssjukhuset
Linköping, 58185
Regionsjukhuset i Örebro
Örebro, 70185
Huddinge Sjukhus
Stockholm, 14186
United Kingdom4 sites
University of Wales
Cardiff, CF4 4XN
Ninewells Hospital
Dundee, DDI 954
Falkirk and District Royal Infirmary
Falkirk, F1 5QE
Glasgow University Hospital
Glasgow, GI2 8QQ
France2 sites
Hôpital Sainte-Marguerite
Marseille, 13277
Service de Dermatologie, C.H.U Saint Louis
Paris, 754747
About this study
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
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.
Read the detailed description
BCC was 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 was 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 was attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience was promising and participants with primary BCCs were 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 is the number of participants 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 analysed. The analysis based on the results of the independent review board constitutes the primary analysis.
The secondary end-points was the proportion of participants in whom less than 75% of the BCC lesions respond completely, number of lesions across participants 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 was assessed.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- Metvix® cream, Hand held liquid nitrogen spray cryotherapy
- Keywords
- Methyl aminolevulinate, Photodynamic therapy, Primary Superficial Basal Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix® creamDrug
Also called Methyl 5-aminolevulinate hydrochloride
Hand held liquid nitrogen spray cryotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Hand held liquid nitrogen spray cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Complete response was defined as no clinically visible BCC lesions in the treatment area.
Measured: 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
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.
Measured: 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
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.
Measured: 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months)
Recurrence Rate in Complete Clearance Group
Recurrence rate in complete clearance group was analyzed.
Measured: 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
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.
Measured: 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study start18 Oct 1999
- Primary completion5 Sep 2001
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nicole Basset-Séguin, Professor, Principal investigator, Saint-Louis Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469417
- Sponsor's protocol ID
- PC T304/99
- Status last verified
- Mar 2024
- First submitted
- 3 May 2007
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00469417
- Acronym / sponsor ID
- PC T304/99
- Conditions
- Superficial Basal Cell Carcinoma
- Keywords
- Methyl aminolevulinate, Photodynamic therapy, Primary Superficial Basal Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 1999 (actual)
- Primary completion
- 5 Sep 2001 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BCC was 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 was 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 was attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience was promising and participants with primary BCCs were 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 is the number of participants 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 analysed. The analysis based on the results of the independent review board constitutes the primary analysis.
The secondary end-points was the proportion of participants in whom less than 75% of the BCC lesions respond completely, number of lesions across participants 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 was assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metvix® PDT | Experimental | Drug: Metvix® creamParticipants 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. |
| Cryotherapy | Active comparator | Procedure: Hand held liquid nitrogen spray cryotherapyCryotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- A participant or lesion fulfilling any of the following criteria was ineligible for inclusion:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metvix® creamAlso: Methyl 5-aminolevulinate hydrochloride | Drug | Metvix® PDT |
| Hand held liquid nitrogen spray cryotherapy | Procedure or surgery | Cryotherapy |
Primary outcome
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle
Time frame: 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months
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.
5 secondary outcomes
Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle
Time frame: 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
Time frame: 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
Time frame: 3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months)
Recurrence Rate in Complete Clearance Group
Time frame: 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
Time frame: 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Basset-Séguin, Professor principal investigator
Saint-Louis Hospital, Paris
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metvix® cream and Hand held liquid nitrogen spray cryotherapy in people with Superficial Basal Cell Carcinoma, run by Galderma R&D at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Sweden, United Kingdom, France, Austria, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle (time frame: 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.