EFFICACY TREATMENT OF ACNE VULGARIS 97 need for a well-tolerated local therapy that is more effective, cheaper, and without the risk of side effects. Furthermore, it appears that a new method can offer faster resolution, less scarring, and fewer side effects, resulting in greater patient satisfaction. Acne Dressing® (3M Health Care), a hydrocolloid dressing containing gel-forming agents such as sodium carboxymethylcellulose (NaCMC) and gelatin embedded in an adhesive matrix covered by polyurethane film, has a high absorptive capacity. It is ventilated and waterproof to provide an environment that leads to wound closure and protection of the wound from infection. Hydrocolloid sheets are widely used as a primary dressing in the management of different types of wounds including acute and chronic wounds, pressure sores, donor sites, and burns. Hydrocolloid dressings have been shown to be effective in treating psoriasis vulgaris (7), lichen amyloidosus (8), and venous leg ulcers (9). Zeegelaar et al. (9) indicate that hydrocolloid dressings might function well in the extremely humid conditions of tropical climates. Van Vlijmen-Willems et al. (7) confirm the anti-psoriatic effect of hydrocolloid dressings and demonstrate that their effect upon inflammation is modest. The characteristics of high absorptive capacity, ventilation, and being waterproof allow Acne Dressing® to absorb sebum production in order to decrease inflammation and avoid contamination from hand touching or air pollution. MATERIAL AND METHODS PATIENTS A total of 20 patients, aged 11 to 35 years, with facial acne, who met all study inclusion and exclusion criteria were enrolled in the study (Table I). These patients presented to the Department of Dermatology at Tri-Service General Hospital over a one-week study period. Inclusion criteria required patients to be ten years or older and to have mild- to-moderate facial acne. Medication-free periods were required before study entry, except for oral antibiotics. Patients were required to understand and follow the study protocol, and written informed consent was obtained from all the participants in the study. This study was a randomized, double-blind study, with an active and a control group. The control group was given a treatment identical to the base of Acne Dressing®. To maintain investigator masking, clinical assistants collected and recorded data according to facial skin signs and symptoms, and investigators assessed efficacy measures. Patients Table I Inclusion and Exclusion Criteria Inclusion criteria Patients who reported mild-to-moderate inflamed acne with lesion size 1 cm The only form of acne treatment allowed for an eligible patient is an oral antibiotic Reliable and cooperative patients able to follow all study procedures Patients who understand and sign the informed consent form Exclusion criteria Patients who have any facial skin disease (apart from acne vulgaris) such as psoriasis or eczema that may interfere with the study procedures Patients using facial topical medicine or receiving any hormone therapy Allergy or hypersensitivity to hydrocolloids
98 JOURNAL OF COSMETIC SCIENCE were randomly assigned to two treatment groups, each having ten enrollees: (a) patients in group I received Acne Dressing® as a treatment application and (b) patients in group II received skin tapes as a treatment application. Each group used Acne Dressing® or skin tapes on days 1 (baseline), 3, 5, and 7. The application size was determined by the size of the patient's acne lesions. Each patient was photographed in a room with a constant temperature of 20°C and a constant relative humidity of 40-50%. Photographs of the front and bilateral facial views of each patient were taken at each visit. After five minutes, the Acne Dressing® or skin tapes were applied to inflamed papules (0.5 cm to 1.0 cm). The tapes were changed every two days by the same investigator. CLINICAL ASSESSMENT Patients were seen at baseline, defined as the visit when treatment was initiated, and again at 3, 5, and 7 days of treatment. The physician used three methods to assess acne at each visit. First, the "overall acne severity grade" was assessed by using Dr. Cunliffe's (11) grading system before and after treatment. According to this system, the grading scale was O (no acne whatsoever) to 10 (the most severe acne). The scale for the depth and width of acne lesions is: 0.25, a few small inflamed lesions 0.5, small inflammatory lesions over a wider area 1.0, more intensely inflamed lesions 1.5, intensely inflamed lesions over a wider area 2.0, deeper but non-nodular lesions 2.5, lesions similar to those in grade 2.0 but over a greater area and 3.0, much of the face involved with intensely inflamed but non-nodular lesions. Second, comparing the patients' condition with baseline photographs, the physician and the patients assessed responses to the treatment questionnaire. The questionnaire included demographic data (age and gender) and assessment of dryness, redness, oiliness, and dark pigmentation. Most questions used a five-point Likert scale with responses from "strongly disagree" to "strongly agree." At the followup visit the physician and patients assessed clinical efficacy and beneficial effects. Third, biometrological assessments were made each time after washing the face in the morning. The participants had not been allowed to wash their faces or apply cosmetics or any other topical products during the previous 15 hours. They were asked not to drink any fluids and to refrain from touching the area under investigation. At each evaluation time, the Sebumeter SM810R (C + K Electronic, Cologne, Germany) was used to assess the sebum casual level (CL, µg/cm2) before application of Acne Dressing® or skin tapes. ULTRA VIOLET B PENETRATION TEST Lambda 800 UV/VIS Spectrometer, a double mono-chromator optical system capable of doing classical transmission, absorption, and reflectance measurements in the range of 180 nm A. 3300 nm, was used to test the penetration of UVB light through Acne Dressing® and skin tapes. Measuring the transmission through both types of tape can enable us to understand the properties of the materials and is useful in avoiding UVB damage to the skin. STATISTICAL ANALYSIS The mean of the values of each biometrological parameter collected at each of the measurements was calculated for each patient. The data were analyzed using SPSS 11.0
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