Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Metvix PDT
|
Procedure: Metvix 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 [Baseline and Month15]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Dermatology of Manchester Royal Infirmary | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: John T. Lear, MB,Ch.B,M.D, Manchester Royal Infirmary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD.03.SPR.29061
- Eudract # :2008-001603-30
Study Results
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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Metvix® Photodynamic Therapy (PDT) |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 9 |
| COMPLETED | 7 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Metvix PDT |
|---|---|
| Arm/Group Description | |
| Overall Participants | 9 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
7
77.8%
|
| >=65 years |
2
22.2%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.8
(8.89)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
11.1%
|
| Male |
8
88.9%
|
| Region of Enrollment (participants) [Number] | |
| United Kingdom |
9
100%
|
Outcome Measures
| Title | Percent Change From Baseline in Lesion Count at Week 18 |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Metvix® Photodynamic Therapy (PDT) |
|---|---|
| Arm/Group Description | |
| Measure Participants | 8 |
| Mean (Standard Deviation) [percent change] |
95.5
(9.1)
|
| Title | Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 |
|---|---|
| Description | |
| Time Frame | Baseline and Month15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Metvix® Photodynamic Therapy (PDT) |
|---|---|
| Arm/Group Description | |
| Measure Participants | 9 |
| Mean (Standard Deviation) [Percent change from baseline] |
71
(41.4)
|
Adverse Events
| Time Frame | From Screening visit up to Month 15/early termination visit | |
|---|---|---|
| Adverse Event Reporting Description | Questioning of subjects at each follow up visit | |
| Arm/Group Title | Metvix® Photodynamic Therapy (PDT) | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Metvix® Photodynamic Therapy (PDT) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Metvix® Photodynamic Therapy (PDT) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | |
| Infections and infestations | ||
| Urinary Track Infection | 1/9 (11.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Metvix® Photodynamic Therapy (PDT) | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/9 (100%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 2/9 (22.2%) | 2 |
| Endocrine disorders | ||
| Hyperparathyroidism | 1/9 (11.1%) | 1 |
| Eye disorders | ||
| Cataract | 1/9 (11.1%) | 1 |
| Gastrointestinal disorders | ||
| Vomiting | 1/9 (11.1%) | 1 |
| General disorders | ||
| Application site pain | 2/9 (22.2%) | 2 |
| Influenza Like illiness | 1/9 (11.1%) | 1 |
| Infections and infestations | ||
| Cellulitis | 1/9 (11.1%) | 1 |
| Gastroenteritis viral | 1/9 (11.1%) | 1 |
| Lower respiratory tract infection viral | 1/9 (11.1%) | 1 |
| Upper respiratory tract infection | 1/9 (11.1%) | 1 |
| Urinary tract infection | 1/9 (11.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Gout | 1/9 (11.1%) | 1 |
| Hyperlipidaemia | 1/9 (11.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Basal cell carcinoma | 1/9 (11.1%) | 1 |
| Skin papilloma | 2/9 (22.2%) | 3 |
| Nervous system disorders | ||
| Migraine | 1/9 (11.1%) | 1 |
| Reproductive system and breast disorders | ||
| Erectile dysfuntion | 1/9 (11.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Actinic keratosis | 5/9 (55.6%) | 10 |
| Telangiectasia | 1/9 (11.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide his draft of such publication to sponsor to review and approve at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
Results Point of Contact
| Name/Title | Farzaneh SIDOU Clinical Project Manager |
|---|---|
| Organization | Galderma |
| Phone | 00 33 4 93 95 70 70 |
| farzaneh.sidou@galderma.com |
- RD.03.SPR.29061
- Eudract # :2008-001603-30