The Nicomide® Improvement in Clinical Outcomes Study (NICOS): Results of an 8-week trial

University of Pittsburgh Medical Center, Pennsylvania, USA.
Cutis; cutaneous medicine for the practitioner (Impact Factor: 0.72). 01/2006; 77(1 Suppl):17-28.
Source: PubMed


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 [123]. "
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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. "
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