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

Phase 4

Completed

• Conditions: Actinic Keratosis
• Interventions: Procedure: Metvix PDT

• Registration Number: NCT01000636
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-06-25
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Results First Posted: 2021-05-26
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metvix PDT	Metvix PDT	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Department of Dermatology of Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom