Actinic KeratosisPhase 4NCT01000636
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
A Phase 4 study testing Metvix PDT in people with Actinic Keratosis, run by Galderma R&D at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Metvix PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Oct 2011
- Phase
- Phase 4
- 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
- Renal transplant with an history of immunosuppression from 5 to 15 years,
- Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.
Who cannot join
- At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
- AK lesions clinically atypical or suspicious for malignancy on the target field,
- Any of the following topical treatments within the specified washout period at Screening:
- 5-FU, Imiquimod, Diclofenac sodium: 3 months,
- Cryotherapy: 3 months,
- PDT: 3 months,
- Other less common AK treatments: 3 months.
- Systemic retinoids within the last month prior to Screening visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Dermatology of Manchester Royal Infirmary
Manchester, M13 9WL
About this study
Official title: Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.
Read the detailed description
In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.
- Conditions
- Actinic Keratosis
- Being tested
- Metvix PDT
- Keywords
- Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression
- 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 PDTProcedure or surgery
Methyl aminolevulinate cream will be applied for 3 hours on the whole target field.
The target field will then be exposed to red light using Aktilite 128 lamp.
| Study group | Role | What they receive |
|---|---|---|
| Metvix PDT | Experimental | Not described Receives: Procedure: Metvix PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lesion Count at Week 18
Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
Measured: Baseline and Week 18.
Secondary outcomes (1)
Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
Measured: Baseline and Month15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
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 KeratosisStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John T. Lear, MB,Ch.B,M.D, Principal investigator, Manchester Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000636
- Sponsor's protocol ID
- RD.03.SPR.29061
- Other IDs
- Eudract # :2008-001603-30
- Status last verified
- May 2021
- First submitted
- 22 Oct 2009
- Last updated
- 26 May 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 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT
- ClinicalTrials.gov ID
- NCT01000636
- Acronym / sponsor ID
- RD.03.SPR.29061
- Conditions
- Actinic Keratosis
- Keywords
- Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 26 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.
Detailed description
In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metvix PDT | Experimental | Procedure: Metvix 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)
- Renal transplant with an history of immunosuppression from 5 to 15 years,
- Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.
Key exclusion criteria (8 listed)
- At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
- AK lesions clinically atypical or suspicious for malignancy on the target field,
- Any of the following topical treatments within the specified washout period at Screening:
- Systemic retinoids within the last month prior to Screening visit.
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 PDTMethyl aminolevulinate cream will be applied for 3 hours on the whole target field. The target field will then be exposed to red light using Aktilite 128 lamp. | Procedure or surgery | Metvix PDT |
Primary outcome
Percent Change From Baseline in Lesion Count at Week 18
Time frame: Baseline and Week 18.
Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
1 secondary outcome
Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
Time frame: Baseline and Month15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
John T. Lear, MB,Ch.B,M.D principal investigator
Manchester Royal Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metvix PDT in people with Actinic Keratosis, run by Galderma R&D at 1 site in United Kingdom.
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 8 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 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 26 May 2021). 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?
Percent Change From Baseline in Lesion Count at Week 18 (time frame: Baseline and Week 18.). 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 26 May 2021.