Photodynamic Therapy for Papulopustular Rosacea

Inclusion criteria

• Ages 18-79 years
• 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.
• 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

• < 18 or > 79 years of age
• Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle
• Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit 1
• Use of systemic antibiotics within 1 month prior to Visit 1
• Use of topical retinoids (on the face) within 1 month prior to Visit 1
• Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1.
• Use of laser or light based rosacea treatments (on the face) within 1 month prior to Visit 1
• Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within 2 months prior to Visit 1
• Use of topical corticosteroids (on the face) 1 month prior to Visit 1
• Use of systemic corticosteroids 3 months prior to Visit 1
• Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview
• History of adverse reaction to light exposure
• History of disorder of porphyrin metabolism
• Scarring or infection in the area being treated
• Extensive facial hair that would either impair blue light exposure or interfere with lesion evaluation
• Inability to make study visits or anticipated poor compliance
• 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.
• Life threatening illness that would interfere with the patient's ability to complete the study
• Participation in another clinical experimental therapeutic study within 30 days of screening visit
• 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.