Last updated on August 2018

Photodynamic Therapy for Papulopustular Rosacea


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rosacea
  • Age: Between 18 - 79 Years
  • Gender: Male or Female

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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