Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Methylaminolevulinate (Metvix, Metvixia); Photodynamic Therapy (Aktilite)
Intervention description: 2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4.; Device set to 37 J/cm². Red light wavelength is approximately 630 nm.
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic keratoses; actinic keratosis; methylamonolevulinate; photodynamic therapy; without occlusion; short incubation

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.