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Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Metvix PDT

About this trial

This is an interventional other trial for Actinic Keratosis focused on measuring Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Dermatology of Manchester Royal Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metvix PDT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15

Full Information

NCT ID

NCT01000636

First Posted

October 22, 2009

Last Updated

May 4, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01000636

Brief Title

Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

Official Title

Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metvix PDT

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Metvix PDT

Intervention Description

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.

Primary Outcome Measure Information:

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.

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John T. Lear, MB,Ch.B,M.D

Organizational Affiliation

Manchester Royal Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology of Manchester Royal Infirmary

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

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