Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: aminolevulinic acid HCL (ALA); Vehicle (VEH)
Intervention description: Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.; Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Photodynamic Therapy

Summary:

      The purpose of this study is to determine and compare the safety and efficacy of multiple
      broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle
      (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or non-pregnant female 12 years of age or older.

          -  Females must be post-menopausal, surgically sterile or using a medically acceptable
             form of birth control, with a negative urine pregnancy test at the Baseline visit.

          -  Subject has provided written and verbal informed consent. A subject under 18 years of
             age must be accompanied by the parent or legal guardian at the time of assent/consent
             signing. The parent or legal guardian must also provide informed consent for the
             subject.

          -  Subject has moderate to severe facial acne vulgaris (including the nose), with at
             least 20 inflammatory lesions (papules, pustules, nodules).

          -  Subject has moderate to severe acne as defined by an Investigator Global Assessment of
             3 or 4 [0 (clear) to 4 (severe) scale].

          -  Subject has a history of recurrent herpes simplex labialis infection in the treatment
             area AND has had an outbreak within the last 12 months must be placed on antiviral
             prophylaxis as specified in the protocol.

          -  Subject is willing to comply with study instructions and return to the clinic for
             required visits.

          -  Subject must have used the same type and brand of make-up, other facial products and
             hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior
             to the Baseline Visit (General Skin & Hair Care). Upon enrollment, all subjects must
             a) use exclusively an Investigator approved facial cleanser and b) agree to continue
             their other General Skin & Hair Care for the entire study.

        Exclusion Criteria:

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study.

          -  Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to
             porphyrins or photodermatosis.

          -  Subject has any skin pathology or condition that could interfere with the evaluation
             of the test product or requires the use of interfering topical or systemic therapy.

          -  Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5
             cm in diameter)

          -  Subject has an uncorrected coagulation defect or concurrently uses anticoagulants
             (except aspirin).

          -  Subject has any condition which, in the investigator's opinion, would make it unsafe
             for the subject to participate in this research study.

          -  Subject is currently enrolled in an investigational drug or device study.

          -  Subject has received an investigational drug or been treated with an investigational
             device within 30 days prior to the initiation of treatment (baseline).

          -  Subject has facial hair that could interfere with the study assessments in the opinion
             of the investigator.

          -  Subject is unable to communicate or cooperate with the investigator due to language
             problems, poor mental development, or impaired cerebral function.

          -  Subject may be unreliable for the study including subjects who engage in excessive
             alcohol intake or drug abuse, or subjects who are unable to return for scheduled
             follow-up visits.

          -  Subject has a known sensitivity to one or more of the vehicle components (ethyl
             alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).

          -  Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa
             antibiotics, phenothiazines, etc. within a timeframe where photosensitization from
             these drugs may still be present.

          -  Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the
             initiation of treatment.

          -  Subject has the need or plans to be exposed to artificial tanning devices or excessive
             sunlight during the trial.

          -  Subject has used any of the following topical anti-acne preparations on the face: a.)
             Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid,
             corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.)
             Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation
             of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks
             of the initiation of treatment.

          -  Subject has used any of the following systemic anti-acne medications: a.)
             Corticosteroids (including intramuscular and intralesional injections) within 4 weeks
             of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable
             (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to
             the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of
             treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of
             treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.)
             Retinoid therapy within 6 months of the initiation of treatment.