Basal Cell CarcinomaPhase 3NCT00472108
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
A Phase 3 study testing Photodynamic Therapy (PDT) and Metvix cream in people with Basal Cell Carcinoma, run by Galderma R&D at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Photodynamic Therapy (PDT) and Metvix cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2000to Apr 2002
- 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 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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 30 days.
- Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative 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 larger than 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Department of Dermatology, Roswell Park Cancer Institue
Buffalo, New York, 14263
Texas Dermatology Research Institute
Dallas, Texas, 75230
Department of Dermatology, University of Minnesota Hospital and Clinic
Minneapolis, Minnesota, 55455
Virginia Clinical Research, Inc.
Norfolk, Virginia, 230507
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Department of Dermatology, Mayo Medical School, Mayo Clinic
Rochester, Minnesota, 55905
Clinical Research Specialists Inc
Santa Monica, California, 90404-2115
About this study
Official title: A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
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.
Read more
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.
Read the detailed 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Photodynamic Therapy (PDT), Metvix cream, Placebo Cream
- Keywords
- Nodular Basal Cell Carcinoma, Basal Cell Carcinoma, PDT with Metvix 160 mg/g cream, PDT with placebo cream, Histological verification
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic Therapy (PDT)Radiation
Metvix creamDrug
Placebo CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g) | Experimental | Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. Receives: Radiation: Photodynamic Therapy (PDT); Drug: Metvix cream |
| Placebo Cream | Placebo comparator | Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm*2 and fluency rate of 50-200 mW/cm*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. Receives: Radiation: Photodynamic Therapy (PDT); Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Histologically Confirmed Complete Response
The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
Measured: up to 9 months
Secondary outcomes (7)
Percentage of Lesions With Histologically Confirmed Complete Lesion Response
Histological response weight means no signs of malignant basal cells in all microscopical slides containing excised tissue. The histologically confirmed complete lesion response were reported.
Measured: up to 9 months
Percentage of Lesions With Clinically Confirmed Complete Lesion Response
Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. The clinically confirmed complete lesion response were reported.
Measured: up to 9 months
Histological Verified Lesions With Complete Response
Histological confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of histologically confirmed lesions with complete response were reported.
Measured: up to 9 months
Clinically Verified Lesions With Complete Response
Clinically confirmed complete lesion response means no signs of malignant basal cells in all microscopical slides containing excised tissue. Number of clinically confirmed lesions with complete response were reported.
Measured: up to 9 months
Number of Participants With Clinically Evaluated Complete Response
The on-site investigator evaluated the lesion response by comparing to the lesion size before and after treatment. Complete response here means complete disappearance of a lesion. Number of participants for whom one or more lesions had a complete response were reported.
Measured: up to 9 months
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Cosmetic outcomes were assessed with regards to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. Cosmetic outcome were graded as excellent, good, fair or poor where: excellent: no scarring, atrophy or induration, no or slight occurrence of redness or change in pigmentation compared to 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 and Poor: extensive occurrence of scarring, atrophy or induration. The investigator and participants assessed the cosmetic outcome for each lesion has responded completely. Participants were asked to evaluate evaluate the cosmetic outcome according to the same categories: excellent, good, fair cosmetic outcome. Number of participants with summarized cosmetic outcomes for all symptoms as assessed by Investigator and participants were reported.
Measured: up to 9 months
Number of Participants With Adverse Events and Serious Adverse Events (AEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with AEs and serious AEs were reported.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startDec 2000
- Primary completionApr 2002
- Study completionApr 2002
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 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
- Double blind
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Whitney Tope, MPhil, MD, Principal investigator, University of Minnesota Hospital and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472108
- Sponsor's protocol ID
- PC T307/00
- Status last verified
- Feb 2024
- First submitted
- 10 May 2007
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00472108
- Acronym / sponsor ID
- PC T307/00
- Conditions
- Basal Cell Carcinoma
- Keywords
- Nodular Basal Cell Carcinoma, Basal Cell Carcinoma, PDT with Metvix 160 mg/g cream, PDT with placebo cream, Histological verification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2000 (actual)
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g) | Experimental | Radiation: Photodynamic Therapy (PDT), Drug: Metvix creamParticipants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. |
| Placebo Cream | Placebo comparator | Radiation: Photodynamic Therapy (PDT), Drug: Placebo CreamParticipants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm*2 and fluency rate of 50-200 mW/cm*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Photodynamic Therapy (PDT) | Radiation | Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g), Placebo Cream |
| Metvix cream | Drug | Photodynamic Therapy (PDT) WIth Metvix Cream 160 milligrams/gram (mg/g) |
| Placebo Cream | Drug | Placebo Cream |
Primary outcome
Number of Participants With Histologically Confirmed Complete Response
Time frame: up to 9 months
The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response was defined as complete disappearence of lesion. Number of participants with histologically confirmed complete response were reported.
7 secondary outcomes
Percentage of Lesions With Histologically Confirmed Complete Lesion Response
Time frame: up to 9 months
Percentage of Lesions With Clinically Confirmed Complete Lesion Response
Time frame: up to 9 months
Histological Verified Lesions With Complete Response
Time frame: up to 9 months
Clinically Verified Lesions With Complete Response
Time frame: up to 9 months
Number of Participants With Clinically Evaluated Complete Response
Time frame: up to 9 months
Number of Participants With Cosmetic Outcome Assessed by Investigator and Participants
Time frame: up to 9 months
Number of Participants With Adverse Events and Serious Adverse Events (AEs)
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
Whitney Tope, MPhil, MD principal investigator
University of Minnesota Hospital and Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photodynamic Therapy (PDT) and Metvix cream in people with Basal Cell Carcinoma, run by Galderma R&D at 9 sites in United States.
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 6 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 5 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 9 sites in United States. 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. Some participants in this study may receive a placebo. 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 5 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?
Number of Participants With Histologically Confirmed Complete Response (time frame: up to 9 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 5 Aug 2024.