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Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Phase 3 trial testing Metvix-PDT in Actinic Keratosis in 131 participants. Completed in 23 January 2007.
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 131 |
| Start date | 13 March 2006 |
| Primary completion | 23 January 2007 |
| Estimated completion | 23 January 2007 |
| Sites | 11 locations across United States, Germany |
Galderma R&D — full company profile →
18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.
| Group | Value | 95% CI |
|---|---|---|
| Metvix-PDT | 68.4 | 54.8 – 80.1 |
| Vehicle-PDT | 6.9 | 1.9 – 16.7 |
Lesion complete response rate was defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) after treatment. Percentage of lesions reported by location.
| Group | Value | 95% CI |
|---|---|---|
| Metvix-PDT | 89 | |
| Vehicle-PDT | 28 |
| Group | Value | 95% CI |
|---|---|---|
| Metvix-PDT | 81 | |
| Vehicle-PDT | 30 |
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with at least one treatment site adverse events were reported.
| Group | Value | 95% CI |
|---|---|---|
| Metvix-PDT | 61 | |
| Vehicle-PDT | 27 |
Time frame: From study drug administration up to Week 13. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Metvix-PDT | Vehicle-PDT |
|---|---|---|---|
| Cerebral Concussion | Injury, poisoning and procedural complications | — | — |
| Hospitalization for coronary cateterization | Investigations | — | — |
| Basal cell carcinoma nose surgery | Surgical and medical procedures | — | — |
| Surgery of squamous cell carcinoma right cheek | Surgical and medical procedures | — | — |
| Re-surgery of squamous cell carcinoma right cheek | Surgical and medical procedures | — | — |
| Lentigo maligna surgery | Surgical and medical procedures | — | — |
| Planned three-step surgery of preexisting squamous cell carcinoma | Surgical and medical procedures | — | — |
| Basal cell carcinoma left cheek surgery | Surgical and medical procedures | — | — |
| Re-surgery and wound suture basal cell carcinoma left cheek | Surgical and medical procedures | — | — |
| Knee prothesis right due to arthrosis participants affected / exposed | Surgical and medical procedures | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Retrograde amnesia and anterograde amnesia due to cerebral concussion | Nervous system disorders | — | — |
| Inguinal hernia | Gastrointestinal disorders | — | — |
| Reaction | System | Metvix-PDT | Vehicle-PDT |
|---|---|---|---|
| Pain of skin | Skin and subcutaneous tissue disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Skin burning sensation | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Skin exfoliation | Skin and subcutaneous tissue disorders | — | — |
| Scab | Skin and subcutaneous tissue disorders | — | — |
| Skin discomfort | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Cerebral Concussion, Hospitalization for coronary cateterization, Basal cell carcinoma nose surgery, Surgery of squamous cell carcinoma right cheek, Re-surgery of squamous cell carcinoma right cheek, Lentigo maligna surgery, Planned three-step surgery of preexisting squamous cell carcinoma, Basal cell carcinoma left cheek surgery.
Data from ClinicalTrials.gov NCT00304239 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing