Phase 3
N=20
Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT00926952 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Feb 2011
Primary outcome: Primary: Mean Number of Facial Actinic Keratoses at Week 12 — 2.70 Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methylaminolevulinate (Metvix, Metvixia) (Drug); Photodynamic Therapy (Aktilite) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Innovaderm Research Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Facial Actinic Keratoses at Week 12 |
2.70 | — |
| SECONDARY Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12 |
3 | — |
| SECONDARY Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12 |
197; 143 | — |
| SECONDARY Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12 |
4.85 | — |
| SECONDARY Mean Fine Wrinkling Score at Week 12 |
4.30 | — |
| SECONDARY Mean Coarse Wrinkling Score at Week 12 |
4.55 | — |
| SECONDARY Mean Sallowness Score at Week 12 |
3.10 | — |
| SECONDARY Mean Mottled Hyperpigmentation at Week 12 |
4.40 | — |
| SECONDARY Number of Adverse Events |
11; 0 | — |
Summary
Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older.
- Patient with at least 5 actinic keratoses of the face at Day 0.
- Patient was willing to use an adequate contraceptive method or was surgically sterile, post menopausal, abstinent or with a same sex partner. Adequate means of contraception included oral contraceptives, IUD in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0.
- Patient capable of giving informed consent.
Exclusion Criteria
- Patient with allergy to methylaminolevulinate or any component of the vehicle which includes peanut and almond oil.
- Patient with clinically significant sensitivity to visible light, porphyria or porphyrin sensitivity.
- Patient used any topical treatment for actinic keratoses (including imiquimod and 5-fluouracil), on the face within 4 weeks preceding Day 0.
- Patient had cryotherapy or surgery on the face within 4 weeks preceding Day 0.
- Patient with any malignant skin lesion (such as basal cell carcinoma, invasive squamous cell carcinoma or Bowen's disease) on the face at Day 0.
- Patient used photodynamic therapy, with any topical or systemic photosensitizer within 8 weeks preceding Day 0.
- Patient was exposed to excessive ultraviolet radiation (UVB phototherapy, sun tanning salons) within the 4 weeks preceding Day 0.
- Patient used any investigational drug within 4 weeks preceding Day 0.
- Patient with problems of alcoholism or drug abuse in the past year.
- Patient with any unstable or serious uncontrolled medical condition.
- Current pregnancy or lactation.
- Patient with any serious dermatological disorder, including malignancies that would either put the patient at risk or interfere with efficacy or safety evaluations.
- Patient with Fitzpatrick phototype IV, V or VI (inadequate penetration of red light in dark skinned subjects.
- Patients with extensive facial hair (e.g., beard) that would either impair red light exposure or interfere with lesion evaluation.
Data sourced from ClinicalTrials.gov (NCT00926952). 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.