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 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction