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

NCT01000636 | Completed Phase 4 Results

• 2 other identifiers: RD.03.SPR.29061Eudract # :2008-001603-30
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and Month15

Study Arms (1)

Metvix PDT

EXPERIMENTAL

Procedure: Metvix PDT

Interventions

Metvix PDT PROCEDURE

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.

Metvix PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Department of Dermatology of Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

No limitation or caveat on this study

Results Point of Contact

• Title: Farzaneh SIDOU Clinical Project Manager
• Organization: Galderma

farzaneh.sidou@galderma.com

00 33 4 93 95 70 70

Study Officials

• John T. Lear, MB,Ch.B,M.D

  Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Locations

GB (1)