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Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients

2014-08-27 03:12:17 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Acne Vulgaris

Intervention

Visonac

Location

DermResearch, Inc.
Austin
Texas
United States
78759

Status

Not yet recruiting

Source

PhotoCure

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:17-0400

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Medical and Biotech [MESH] Definitions

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

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Acne
Acne is a common skin condition that causes spots to develop on the skin, usually on the face, back and chest..  The spots can range from blackheads and whiteheads which are often mild, to inflamed pus-filled pustules and cysts, which can be severe ...


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