96 JOURNAL OF COSMETIC SCIENCE which is associated with significant medical, social, and psychological problems (1-3). In recent years, advances in the understanding of the pathophysiology of acne and acne inflammation have led to the development of new therapeutic agents and new manage- ment methods. However, many patients hope to negotiate adolescence with fewer of the embarrassing stigmata of acne that impact so unfavorably on the quality of life in this age group. Furthermore, there is the potential to prevent the lasting sequela (e.g. scarring, post-inflammatory hyperpigmentation) of this disease in many of patients. Acne vulgaris is a multifactorial disease that essentially involves the pilosebaceous unit, composed of the hair follicle and adjacent sebaceous glands. Although the etiology of acne involves multi-related factors, a large amount of evidence implicates an increased rate of sebum production, which is mainly controlled by hormones. Sebum is a lipid-rich secretion product of the sebaceous glands, which has an important role in the patho- genesis of acne and provides a growth medium for Propionibacteria acnes (P. acnes), which lead to the production of inflammatory mediators that engender the papules, pustules, and later nodulocystic lesions typical of inflammatory acne. However, inflammation, which is a characteristic reaction of tissue to disease or injury and is marked by four signs, i.e., swelling, redness, heat, and pain, is a direct or indirect result of the prolif- eration of P. acnes. Sebaceous follicles containing microcomedones provide an anaerobic, lipid-rich environment in which these bacteria flourish (3). Moreover, the study of Pochi and Strauss (4) indicated that the severity of acne is generally related to the amount of sebum production. The characteristic localization of acne to the face and upper trunk is a result of the distribution of oil-secreting structures known as sebaceous glands within the hair follicles. Clinical research has shown that many factors, such as hormones, sebaceous gland hyperplasia with seborrhea, bacteria, food, genetics, drugs, occupation, and stress, are related to the pathogenesis of acne. Moreover, environmental factors, including climate and ultraviolet light, are also thought to be important in the aggravation of acne. Many researchers indicated that acne is aggravated in hot and humid weather (2). The weather in Taiwan is hot and windless, which make peoples' sebaceous glands become hyper- plasic with seborrhea. The expectancy of many acne patients is to improve or cover the inflamed acne and reduce the severity of inflammation. Gfesser and Worret (5) indicated that sunbathing may be beneficial for psychological reasons and may produce euphoric effects, but they do not see any reason to treat acne with ultraviolet radiation because of its negative effects on the skin. The dispute about the effect of sunlight on acne was further complicated by Hjorth et al. (6). "Acne aestivalis" is named for the acne patients who complained of the aggravation of acne lesions in summer. They considered that the main causative factor is sunlight. However, the precise role of ultraviolet light in the development and irritation of acne lesions is not certain. Additionally, the eastern female likes to use artistically irregular tapes (e.g., surgical tapes) on ugly and inflamed acne in order to make their appearance more beautiful. However, the unsterilized artistic tapes easily induce an occlusion wound, which can increase the level of inflammation. Most Taiwanese believe that squeezing and pinching can decrease the inflammation of acne however, the frequent rubbing and touching of acne lesions leads to infection and the risk of developing scars. Some patients with mild acne consider their condition does not warrant a trip to the doctor and instead prefer a fast, safe and side-effect-free novel therapy. A safe and rapidly effective alternative to current therapy options for acne vulgaris is particularly desirable. Therefore, there is a
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
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]. Cosrnet. Sci., 57, 95-105 (March/April 2006) A pilot study on efficacy treatment of acne vulgaris using a new method: Results of a randomized double-blind trial with Acne Dressing® CHAO-MING CHAO, WEI-YU LAI, BAI-YAO WU, HUNG-CHIA CHANG, WEI-SHUAN HUANG, and YU-FEI CHEN, Department Of Dermatology, Tri-Service General Hospital, 325 Cheng-Kung Road Section 2, Taipei 114, Taiwan, Republic of China. Accepted for publication October 31, 200 5. Synopsis For many years the positive effect of hydrocolloid dressings on skin-related conditions attracted the attention of the medical scientific community. The use of Acne Dressing®, a tape of hydrocolloid dressing, for the treatment of acne has not been reported previously. The aim of this study was to evaluate the clinical efficacy and beneficial effect of Acne Dressing® on the marker for sebum output evaluations. We also determined the cosmetic outcome of this application during the treatment of acne and whether the material could prevent hand touching and UVB light from reaching the skin surface. The objective of this study was to assess improvement in acne vulgaris and tolerability during one week of short contact treatment with Acne Dressing® compared to skin tapes. Efficacy data specific to treatment of acne vulgaris with Acne Dressing® (3M Health Care) from a double-blind, randomized, skin types-controlled study is reported. A total of 20 patients with mild-to-moderate acne vulgaris applied the skin tapes or Acne Dressing® every two days for up to one week. Twenty patients were enrolled in this study: ten patients received Acne Dressing® and ten patients received skin tapes. Both groups showed decreases from baseline to the end of treatment in the mean of the overall severity scale (decrease of 1.37 from 1.8 to 0.43 with Acne Dressing® and 0.28 from 1.08 to 0.8 with skin tapes). A statistically significant greater reduction was observed over a period of three to seven days in the overall severity of acne and inflammation in the Acne Dressing group compared with the mono-therapy (skin tapes) group. Similarly, Acne Dressing® resulted in a significantly greater improvement in the redness, oiliness, dark pigmentation, and sebum casual level at days 3, 5, and 7. The ratio of transmission ofUVB light with Acne Dressing® was 7.4%, and 38% with skin tapes, which shows less UVB light reaching the skin surface with the Acne Dressing®. No significant adverse events were identified in either group. The pilot study shows the benefit of treatment with Acne Dressing® in improving mild-to- moderate inflammatory acne vulgaris. A future study will investigate a large set of patients in longer followup periods. INTRODUCTION Acne vulgaris is an extremely common skin disorder, which in cases of extreme dis- figuration can have severe consequences in the personality development of people and Address all correspondence to Chao-Ming Chao. 95
96 JOURNAL OF COSMETIC SCIENCE which is associated with significant medical, social, and psychological problems (1-3). In recent years, advances in the understanding of the pathophysiology of acne and acne inflammation have led to the development of new therapeutic agents and new manage- ment methods. However, many patients hope to negotiate adolescence with fewer of the embarrassing stigmata of acne that impact so unfavorably on the quality of life in this age group. Furthermore, there is the potential to prevent the lasting sequela (e.g. scarring, post-inflammatory hyperpigmentation) of this disease in many of patients. Acne vulgaris is a multifactorial disease that essentially involves the pilosebaceous unit, composed of the hair follicle and adjacent sebaceous glands. Although the etiology of acne involves multi-related factors, a large amount of evidence implicates an increased rate of sebum production, which is mainly controlled by hormones. Sebum is a lipid-rich secretion product of the sebaceous glands, which has an important role in the patho- genesis of acne and provides a growth medium for Propionibacteria acnes (P. acnes), which lead to the production of inflammatory mediators that engender the papules, pustules, and later nodulocystic lesions typical of inflammatory acne. However, inflammation, which is a characteristic reaction of tissue to disease or injury and is marked by four signs, i.e., swelling, redness, heat, and pain, is a direct or indirect result of the prolif- eration of P. acnes. Sebaceous follicles containing microcomedones provide an anaerobic, lipid-rich environment in which these bacteria flourish (3). Moreover, the study of Pochi and Strauss (4) indicated that the severity of acne is generally related to the amount of sebum production. The characteristic localization of acne to the face and upper trunk is a result of the distribution of oil-secreting structures known as sebaceous glands within the hair follicles. Clinical research has shown that many factors, such as hormones, sebaceous gland hyperplasia with seborrhea, bacteria, food, genetics, drugs, occupation, and stress, are related to the pathogenesis of acne. Moreover, environmental factors, including climate and ultraviolet light, are also thought to be important in the aggravation of acne. Many researchers indicated that acne is aggravated in hot and humid weather (2). The weather in Taiwan is hot and windless, which make peoples' sebaceous glands become hyper- plasic with seborrhea. The expectancy of many acne patients is to improve or cover the inflamed acne and reduce the severity of inflammation. Gfesser and Worret (5) indicated that sunbathing may be beneficial for psychological reasons and may produce euphoric effects, but they do not see any reason to treat acne with ultraviolet radiation because of its negative effects on the skin. The dispute about the effect of sunlight on acne was further complicated by Hjorth et al. (6). "Acne aestivalis" is named for the acne patients who complained of the aggravation of acne lesions in summer. They considered that the main causative factor is sunlight. However, the precise role of ultraviolet light in the development and irritation of acne lesions is not certain. Additionally, the eastern female likes to use artistically irregular tapes (e.g., surgical tapes) on ugly and inflamed acne in order to make their appearance more beautiful. However, the unsterilized artistic tapes easily induce an occlusion wound, which can increase the level of inflammation. Most Taiwanese believe that squeezing and pinching can decrease the inflammation of acne however, the frequent rubbing and touching of acne lesions leads to infection and the risk of developing scars. Some patients with mild acne consider their condition does not warrant a trip to the doctor and instead prefer a fast, safe and side-effect-free novel therapy. A safe and rapidly effective alternative to current therapy options for acne vulgaris is particularly desirable. Therefore, there is a

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