Clinical trial: Photodynamic Therapy for Papulopustular Rosacea (NCT02075671)

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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 79 Years

Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? 0