Clinical trial · Interventional
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metvix-PDT | Combination Product | — | UNRESOLVED |
| Vehicle-PDT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metvix-PDT
- description
- Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.
- interventionNames
- Combination Product: Metvix-PDT
- type
- PLACEBO_COMPARATOR
- label
- Vehicle-PDT
- description
- Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.
- interventionNames
- Combination Product: Vehicle-PDT
Primary outcomes (1)
- measure
- Participant Complete Response Rate (CRR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate. * Males or females above 18 years of age. * Written informed consent. Exclusion Criteria: * Participants with porphyria. * Participants immunosuppressed for idiopathic, disease specific or therapeutic reasons. * Known allergy to MAL, a similar PDT compound or excipients of the cream. * Participants with history of hypersensitivity to nut products or other known protein antigens. * Participation in other clinical studies either currently or within the last 30 days. * Participants receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days. * Participants receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months. * Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment. * Any conditions that may be associated with a risk of poor protocol compliance. * Participants currently receiving regular ultraviolet radiation therapy.
References
Publications (2)
- BACKGROUNDPariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003 Feb;48(2):227-32. doi: 10.1067/mjd.2003.49. PMID 12582393
- BACKGROUNDFreeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118. PMID 12775317