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Acne Vulgaris

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Acne vulgaris is a common skin disease that affects 85-100% of people at some time during their lives. It is characterized by noninflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. Acne vulgaris affects the areas of skin with the densest population of sebaceous follicles; these areas include the face, the upper part of the chest, and the back. 1

Most cases of acne vulgaris are either mild or moderate in severity and well-suited for treatment with nonprescription agents that are safe, effective, and convenient to use. A review of four clinical studies and a comedolytic assay attests to the efficacy and safety of 0.5% and 2% solutions of salicylic acid for the treatment of acne vulgaris. In three placebo-controlled studies and a comedolytic assay, salicylic acid pads reduced the number of primary lesions and thereby the number and severity of all lesions associated with acne. Comparative studies of salicylic acid have shown it to be superior to benzoyl peroxide in reducing the total number of acne lesions. Adverse reactions to salicylic acid are generally limited to mild, local irritation occurring in a minority of patients. 18

The causes of acne vulgaris are not entirely understood. It is partially hereditary, but is associated closely with hormones, stress, hyperactive sebaceous glands, allergic reactions to normal skin bacteria, skin irritation, use of steroids and halogens. Chloride compounds can also cause chloracne. Excluded as specific causes are diet (except where foods cause an allergic reaction or have other ingredients that do cause acne), dirt, and sex, despite common beliefs to the contrary. 3

Acne Rosacea looks very similar to acne vulgaris and they are often confused for one another. Rosacea affects millions of people, most of who are over the age of thirty. Acne Rosacea is a red rash, which is found on the cheeks, nose, forehead and chin. Bumps, pimples, and other skin blemishes accompany it. This form of acne also causes the blood vessels to become more visible on the skin. It is more common in women, but most cases on men are much more severe. 32

In recent years, various naturally occurring substances or synthetic compounds which are antibacterial components safe to the skin have been proposed in the treatment of acne vulgaris. Examples of so-far proposed antibacterial components of natural origin include Ferruginol (see JP-A-1-311018, the term "JP-A" as used herein means an "unexamined published Japanese patent application"), Totarol (see JP-A-1-311019), Sempervirol (see JP-A-1-311020), tetrahydroabietic acid and its esters (see JP-A-2-188513), and anacardic acid (see JP-A-4-36238). may be mentioned as an example of the synthetic antibacterial component to be used in the treatment of acne vulgaris. 8

A genetic background is supported by a case control study by Goulden et al, as noted by Rzany et al (2006). This stated that the risk of adult acne vulgaris in relatives of patients with acne as compared with those of patients without acne is significantly higher [4]. 29

Pentadecanol, which is the active ingredient of the topical composition for treating acne vulgaris according to the present invention, is a straight chain primary alcohol (1-alkanol) having 15 carbon atoms. In general, 1-alkanols are known to possess antibacterial activity, and it was reported that the effectiveness of 1-alkanols considerably varies depending on the object bacteria (see Nobuyuki Kato, et al., J. Antibact. Agents, vol. 8, No. 8

P acnes is a microaerophilic organism present in many acne lesions. Although, it has not been shown to be present in the earliest lesions of acne, the microcomedo, its presence in later lesions is almost certain. The presence of P acnes promotes inflammation through a variety of mechanisms. P acnes stimulates inflammation by producing proinflammatory mediators that diffuse through the follicle wall. Recent studies have shown that P acnes activates the toll-like receptor 2 on monocytes and neutrophils. Activation of the toll-like receptor 2 then leads to the production of multiple proinflammatory cytokines, including IL-12, IL-8, and tumor necrosis factor. Hypersensitivity to P acnes may also explain why some individuals develop inflammatory acne vulgaris while others do not. 1

Even though many types of acne have been discovered as well as the effective treatments of these types, the causes of acne is still very much a mystery. It has been speculated that the causes are factors such as hormones, diet, evolutionary biology, vitamin deficiency, stress and many more. It is very possible that the real answer is a combination of these factors. However, until the cause can be determined the best way to battle this skin condition is with effective treatment. 14

The demographic factors that affected the severity of acne are shown in Table 1. Females were more affected than the males (65% &35%) respectively, no ethnic differences were observed as most of the tribes in the study environment were affected. Acne sufferers had the highest increase in severity during the rainy season. In females, 54.0% indicated an increase in severity during the pre-menstrual period. Also (93.1%) of the acne sufferers indicated increase in severity as a result of stress. While 74.2% of the acne subjects had suffered the disorder for more than 5 years. 31

Acne vulgaris is a chronic disease of sebaceous follicles that is multifactorial in etiology and varies in severity as evidenced by lesion type, size, numbers, scarring, and post-inflammatory pigmentary changes. A variety of drug products, topical and systemic, are currently available to treat acne. Acne occurs more frequently on the face, but can also occur on nonfacial skin (e.g., back, shoulders, chest). 10

Formulations containing a 1-alkanol as an active ingredient for treating acne vulgaris are also known. For example, JP-A-60-152415 discloses a composition containing ethanol as a main ingredient exhibiting antibacterial activity on Propionibacterium acnes, and U.S. Pat. proposes a method for treating acne vulgaris comprising applying a combination of a higher alcohol having from 6 to 12 carbon atoms and a lower alcohol to the affected skin and describes the antibacterial activity of the combination against Corynebacterium acne. teaches gargling with a mixture of water and an alcohol for treatment of acne vulgaris, but the publication does not specify the composition and the effect of the alcohol used. 8

Noninflammatory lesions of acne are the open (blackheads) or closed (whiteheads) comedones. Closed comedones may be more difficult to detect visually and may require stretching of the skin to aid in visualization. These lesions, especially closed comedones, may be precursors to the larger inflammatory lesions and therefore are of clinical importance. 10

Use of 1-alkanols containing from 1 up to 22 carbon atoms as a base of acne vulgaris treating agents for external application has already been disclosed, and 1-pentadecanol is included among these alkanols. However, 1-pentadecanol is not so common as a base, and there is found no specific formulation example using 1-pentadecanol. 8

Only 5.2% of its sufferers had sought doctor’s attention and majority used non-prescription products like creams/lotion (59.8%) and cleansers (32.8%). This corroborates a previous report16 in Caucasian population that acne is believed to be caused by hormonal and genetic factors, diet, poor skin hygiene and infection. 31

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