Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Methyl aminolevulinate (MAL) PDT
Intervention description: Cream application followed by illumination with red light
Intervention MeSH terms: Aminolevulinic Acid; Methyl 5-aminolevulinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 15 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This multicenter study will be divided into 2 phases. The first phase will be an open label,
      dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled,
      parallel-group, dose-response phase. The second phase will only start if the first phase
      succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne
      vulgaris in the face will be included.The results from part 2 has been presented in the
      result section.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female and male patients, age 15 to 40 years with moderate to severe facial acne
             vulgaris (IGA score 3-4).

          2. Patients with skin type I to IV (Fitzpatrick).

          3. Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the
             face excluding lesions on the nose and in the peri-ocular area.

          4. Patients with up to 200 noninflammatory lesions (open and closed comedones) on the
             face.

          5. Patients with no more than 2 nodular lesions on the face.

          6. Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an
             adequate means of contraception including birth control pills, or barrier methods and
             spermicide for at least 14 days prior to Day 0. Patients using birth control pills
             must have used the same product and dose for at least 6 months and must agree to stay
             with the same product and dose for an additional 6 months.

          7. Patients must be willing and capable of following study instructions to the extent and
             degree required by the protocol.

          8. Patients must sign the approved informed consent form prior to any study procedures.

          9. Patients must be willing to be photographed. Patients must be willing to sign a
             photography consent form.

        Exclusion Criteria:

          1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.

          2. Participation in other clinical studies either concurrently or within the last 30
             days.

          3. Patients who have a condition or who are in a situation, which, in the investigator's
             opinion, may put the patient at risk, may confound the study results, or may interfere
             with the patient's participation in the study.

          4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin
             sensitivity.

          5. Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the
             last 30 days.

          6. Patients with a washout period for topical treatments for their acne of less than 14
             days. Medicated cleansers may be used during the washout period and stopped before the
             treatment.

          7. Patients with a washout period for oral antibiotics for treatment of their acne of
             less than 1 month.

          8. Patients with a washout period for oral isotretinoin of less than 6 months.

          9. Patients with a beard or other facial hair that might interfere with study
             assessments.