The Nicomide® Improvement in Clinical Outcomes Study (NICOS): Results of an 8-week trial
ABSTRACT The Nicomide Improvement in Clinical Outcomes Study (NICOS) was an open-label, multicenter, prospective cohort study designed to assess the clinical utility of oral pharmacologic doses of nicotinamide and zinc in 198 patients with acne vulgaris and/or rosacea. The study's primary efficacy measures were patient global evaluation and patient evaluation of the percentage of reduction in inflammatory lesions after 4 and 8 weeks of treatment; overall patient satisfaction also was recorded. The study formulation consisted of nicotinamide 750 mg, zinc 25 mg, copper 1.5 mg, and folic acid 500 microg, marketed as Nicomide (Nic/Zn). Nic/Zn was designed to deliver adequate concentrations of nicotinamide and zinc to effectively treat inflammatory cutaneous conditions with a safety profile suitable for long-term administration. After a relatively short treatment period of 4 weeks, the number of patients enrolled in NICOS who reported improvement was significantly greater (P<.0001) than the number who reported either no change in or worsening of their condition. Of the patients studied, 79% reported their improvement in appearance as moderately better or much better, as measured by patient global evaluation, and 55% reported moderate (26%-50% reduction in lesions) or substantial (>50% reduction in lesions) improvement after 4 weeks of treatment (P<.0001). The percentage of patients who responded to therapy continued to increase through the 8 weeks of treatment. When comparing patients who received concomitant oral antibiotic therapy (51/198, 26%) with those who received Nic/Zn tablets as their only oral therapy (147/198, 74%), the percentage of patients who responded to treatment was not significantly different between treatment groups (P=. 13). This finding was particularly interesting given that most patients studied considered their condition to be of at least moderate severity (143/198, 72%). It appears that the addition of an oral antibiotic to a treatment regimen that includes Nic/Zn tablets may not be necessary because the combination did not significantly increase the percentage of patients responding. Nic/Zn tablets appear to be an effective oral therapy for the treatment of acne vulgaris and rosacea when used alone or with other topical therapies and should be considered a useful alternative approach to oral antibiotics for the treatment of acne vulgaris and rosacea.
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- "In the open-label Nicomide Improvement in Clinical Outcomes Study (NICOS) an oral nutrient combination (750 mg nicotinamide, 25 mg zinc, 1.5 mg copper, 500 mcg folic acid) taken daily for eight weeks appeared to be effective and well tolerated. After four weeks 79% of the subjects demonstrated at least moderate improvement, and the addition of oral antibiotic therapy to one subgroup (51 of the total n of 198) did not provide any additional clinical benefit . "
ABSTRACT: Acne vulgaris is a common dermatological disorder, one that is frequently associated with depression, anxiety and other psychological sequelae. In recent years there has been an increasing focus on the extent to which oxidative stress is involved in the pathophysiology of acne. Emerging studies have shown that patients with acne are under increased cutaneous and systemic oxidative stress. Indeed, there are indications that lipid peroxidation itself is a match that lights an inflammatory cascade in acne. The notion that lipid peroxidation is a 'starter gun' in acne is not a new one; here we review the nearly 50-year-old lipid peroxidation theory and provide a historical perspective to the contemporary investigations and clinical implications. In addition, we present a novel hypothesis in which lipid peroxidation may be priming an increased susceptibility to co-morbid depression and anxiety in those with acne. The emerging research on the systemic burden of oxidative stress in acne sheds further light on the brain-skin axis. The recent findings also suggest potential avenues of approach for the treatment of acne via specific nutrients, dietary modifications, oral and topical interventions.Lipids in Health and Disease 12/2010; 9(1):141. DOI:10.1186/1476-511X-9-141 · 2.22 Impact Factor
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- "Various studies over the last three decades have shown that zinc levels are lower in acne patients than controls, and that oral and topical combination zinc may be of therapeutic value [30-32]. There have also been hints in the literature that insulin and blood sugar abnormalities may be involved in the promotion of acne. "
ABSTRACT: Acne vulgaris is a common skin condition, one that is associated with significant psychological disability. The psychological impairments in acne include higher rates of depression, anxiety, anger and suicidal thoughts. Despite a paucity of clinical research, patients with skin conditions and/or mental health disorders are frequent consumers of dietary supplements. An overlap may exist between nutrients that potentially have both anti-acne and mood regulating properties; examples include omega-3 fatty acids from fish oil, chromium, zinc and selenium. Here we report on five cases of acne treated with eicosapentaenoic acid and antioxidant nutrients. Self-administration of these nutrients may have improved inflammatory acne lesions and global aspects of well-being; the observations suggest a need for controlled trials.Lipids in Health and Disease 11/2008; 7(article 36):36. DOI:10.1186/1476-511X-7-36 · 2.22 Impact Factor
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ABSTRACT: Acne vulgaris is a distressing skin condition which can carry with it significant psychological disability. Patients with acne are more likely to experience anger and are at increased risk of depression, anxiety, suicidal ideation. Certain nutrients which have been implicated as influencing the pathophysiology of acne have also been identified as important mediators of human cognition, behavior and emotions. Zinc, folic acid, selenium, chromium and omega-3 fatty acids are all examples of nutrients which have been shown to influence depression, anger and/or anxiety. These same nutrients, along with systemic oxidative stress and an altered intestinal microflora have been implicated in acne vulgaris. It is our contention that certain nutritional factors, a weakened antioxidant defense system and altered intestinal microflora may interplay to increase the risk of psychological sequelae in acne vulgaris.Medical Hypotheses 02/2007; 69(5):1080-4. DOI:10.1016/j.mehy.2007.02.037 · 1.07 Impact Factor