Photodynamic Therapy for Papulopustular Rosacea
Condition: Rosacea; Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Aminolevulinic acid topical solution 20%; Blu-U Light Therapy; Placebo vehicle only
Intervention description: Intervention used in the experimental arm only; Intervention used in experimental and sham arms; Intervention only includes the placebo vehicle solution
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rosacea; Photodynamic Therapy; Aminolevulinic Acid; Papulopustular Rosacea; Blue Light

Summary:

      Rosacea is a chronic inflammatory disorder that is characterized by severe flushing
      (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical
      therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid
      recurrence is common following the use of systemic antibiotics, resulting in the chronic use
      of these medications to control the disease. Although the exact pathogenesis of rosacea is
      unknown, treatment for this condition has been investigated based on its similarity to acne
      and photodamaged skin. Case reports have shown promising results in rosacea patients treated
      with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which
      observed significant improvement of papules, pustules, erythema, and flushing following 5 -
      aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the
      role of ALA-PDT in the treatment of rosacea has not been reported.

      We have designed a pilot study investigating the efficacy of ALA-PDT in treating
      papulopustular rosacea. The objectives of the study are as follows:

      Primary objective:

        1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules),
           erythema, and telangiectasia of rosacea as assessed by the Investigator's Global
           Assessment (IGA).

        2. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of
           rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).

           Secondary objectives:

        3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical
           Erythema Assessment (CEA) scale.

        4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of
           rosacea as measured by a difference in inflammatory lesion count.

        5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18-79 years

          2. Clinical diagnosis of papulopustular rosacea based on physician evaluation. Only
             patients with 3-50 papules and/or pustules, and a CEA total score ≥ 5, (See Section
             4.1.3) will be enrolled.

          3. History of failing at least one conventional treatment for rosacea (metronidazole,
             sodium sulfacetamide, tetracycline, azelaic acid) or not interested in continuous
             treatment with these agents.

        Exclusion Criteria:

          1. < 18 or > 79 years of age

          2. Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle

          3. Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit
             1

          4. Use of systemic antibiotics within 1 month prior to Visit 1

          5. Use of topical retinoids (on the face) within 1 month prior to Visit 1

          6. Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1.

          7. Use of laser or light based rosacea treatments (on the face) within 1 month prior to
             Visit 1

          8. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or
             microdermabrasion of the face) within 2 months prior to Visit 1

          9. Use of topical corticosteroids (on the face) 1 month prior to Visit 1

         10. Use of systemic corticosteroids 3 months prior to Visit 1

         11. Known or suspected history of drug or alcohol abuse within the past 6 months as
             determined by the medical record or patient interview

         12. History of adverse reaction to light exposure

         13. History of disorder of porphyrin metabolism

         14. Scarring or infection in the area being treated

         15. Extensive facial hair that would either impair blue light exposure or interfere with
             lesion evaluation

         16. Inability to make study visits or anticipated poor compliance

         17. Pregnant females or nursing mothers. Eligible women of reproductive age will be
             required to have a negative urine pregnancy test at screening. They will also be
             required to be on at least one reliable form of effective birth control [examples:
             barrier method (condoms, diaphragm), oral, injectable, implant birth control or
             abstinence] during the course of this study and 30 days following the last treatment
             period.

         18. Life threatening illness that would interfere with the patient's ability to complete
             the study

         19. Participation in another clinical experimental therapeutic study within 30 days of
             screening visit

         20. Any history or evidence of severe illness or any other condition that would make the
             patient, in the opinion of the investigator, unsuitable for the study.