Phase 3
N=131
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT00304239 ↗Enrolled (actual)
131
Serious AEs
6.9%
Results posted
Jul 2023
Primary outcome: Primary: Participant Complete Response Rate (CRR) — 68.4; 6.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metvix-PDT (Combination_product); Vehicle-PDT (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Complete Response Rate (CRR) |
68.4; 6.9 | — |
| SECONDARY Lesion Complete Response Rate |
89; 28; 81; 30 | — |
| SECONDARY Number of Participants With at Least One Treatment Site Adverse Events |
61; 27 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00304239). 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.