Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Open, prospective, randomized, single-centre study in patients with moderate to severe facial
acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4
inflammatory lesions, will be selected in acne-affected areas in the face. One area should be
identified on each cheek and one area should be identified on the forehead. The minimum
distance between the three areas should be at least 4 cm. For each patient the three areas
will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl
alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before
application of the Visonac cream. One of the areas cleaned with saline wipe will also be
occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo
fluorescence spectroscopy will be performed in the three areas before cream application, and
at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence
spectroscopy reading, the cream should be wiped off and the patient should protect the three
areas from sunlight, prolonged, or intense light for 2 days.
The study was extended with additionally 8 patients to explore the photoactive porphyrin
levels over a 24 hour period:
The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream
application. For each patient the three areas will be randomized to Visonac 80mg left on the
skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour.
In vivo fluorescence spectroscopy will be performed at all three areas before cream
application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream
application. The exact time points may be adjusted based on the result from the previously
included patients. All patients will be instructed to protect the three areas from sunlight,
prolonged, or intense light for 2 days.