Phase 4
N=9
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT01000636 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
May 2021
Primary outcome: Primary: Percent Change From Baseline in Lesion Count at Week 18 — 95.5 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metvix PDT (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lesion Count at Week 18 |
95.5 | — |
| SECONDARY Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 |
71 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01000636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.