Actinic KeratosesPhase 3CoMetNCT01475071
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
A Phase 3 study testing Metvix and natural daylight PDT and Metvix and conventional PDT in people with Actinic Keratoses, run by Galderma R&D at 6 sites in Australia.
Trial summary
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Metvix and natural daylight PDT and Metvix and conventional PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesAustralia
- Study dates
- Mar 2012to Mar 2013
- 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
- Male or female above 18 years;
- Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);
Who cannot join
- Subject with clinical diagnosis of at least one severe AK on TAs
- Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
- Subject with pigmented AK on the TAs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Galderma Investigational site
Carlton, Victoria
Galderma Investigational Site
Kogarah, New South Wales
Galderma Investigational site
Phillip, Australian Capital Territory
Galderma Investigational site
Sydney, New South Wales
Galderma Investigational site
Westmead, New South Wales
Galderma Investigational site
Woolloongabba, Queensland
About this study
Official title: Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
- Conditions
- Actinic Keratoses
- Being tested
- Metvix and natural daylight PDT, Metvix and conventional PDT
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix and natural daylight PDTDrug
Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Metvix and conventional PDTDrug
Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
| Study group | Role | What they receive |
|---|---|---|
| Metvix and daylight | Experimental | Not described Receives: Drug: Metvix and natural daylight PDT |
| Metvix and lamp | Active comparator | Not described Receives: Drug: Metvix and conventional PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Response
Percent of lesions treated at Baseline, in complete response at Week 12
Measured: Week12
Pain Score
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Measured: Baseline (during procedure), assessed after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionMar 2013
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 Actinic KeratosesStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Shumack, Principal investigator, St George Dermatology and skin Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475071
- Sponsor's protocol ID
- RD.03.SPR.29102
- Acronym
- CoMet
- Status last verified
- Mar 2016
- First submitted
- 27 Oct 2011
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
- ClinicalTrials.gov ID
- NCT01475071
- Acronym / sponsor ID
- CoMet / RD.03.SPR.29102
- Conditions
- Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metvix and daylight | Experimental | Drug: Metvix and natural daylight PDT |
| Metvix and lamp | Active comparator | Drug: Metvix and conventional PDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female above 18 years;
- Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);
Key exclusion criteria (3 listed)
- Subject with clinical diagnosis of at least one severe AK on TAs
- Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
- Subject with pigmented AK on the TAs
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 and natural daylight PDTMethyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area. | Drug | Metvix and daylight |
| Metvix and conventional PDTMethyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area. | Drug | Metvix and lamp |
Primary outcome
Lesion Response
Time frame: Week12
Percent of lesions treated at Baseline, in complete response at Week 12
Pain Score
Time frame: Baseline (during procedure), assessed after procedure
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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.
Stephen Shumack principal investigator
St George Dermatology and skin Cancer Center
6 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 Metvix and natural daylight PDT and Metvix and conventional PDT in people with Actinic Keratoses, run by Galderma R&D at 6 sites in Australia.
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 2 inclusion and 3 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. 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 18 Apr 2016). 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?
Lesion Response (time frame: Week12). The study lists 2 primary outcomes in all. 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 18 Feb 2021.