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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000636
• Other study ID #: RD.03.SPR.29061
• Secondary ID: Eudract # :2008-
• Status: Completed
• Phase: Phase 4
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Department of Dermatology of Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Week 18.
Secondary	Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15		Baseline and Month15