Actinic Keratosis
Conditions
Keywords
Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression
Brief 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.
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.
Interventions
PROCEDUREMetvix PDT
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.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lesion Count at Week 18 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 | Baseline and Month15 |
Countries
United Kingdom
Participant flow
Recruitment details
9 subjects have been enrolled in one site at United Kingdom. First subject included on: March 11th 2010; Last subject out: October 7th 2011
Participants by arm
| Arm | Count |
|---|---|
| Metvix PDT | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Metvix PDT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 59.8 years STANDARD_DEVIATION 8.89 |
| Region of Enrollment United Kingdom | 9 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
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.
Time frame: Baseline and Week 18.
Population: This trial was of exploratory nature, no statistical rationale for sample size exists. Analysis was performed on Intent to treat (ITT) population that consisted of the entire population enrolled and randomized (i.e., assigned a treatment number). Here, Overall Number of Participants Analyzed = participants with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix® Photodynamic Therapy (PDT) | Percent Change From Baseline in Lesion Count at Week 18 | 95.5 percent change | Standard Deviation 9.1 |
Secondary
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
Population: This trial is of exploratory nature, no statistical rationale for sample size exists. This population consists of the entire population enrolled and randomized (i.e., assigned a treatment number).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix® Photodynamic Therapy (PDT) | Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 | 71 Percent change from baseline | Standard Deviation 41.4 |