The Impact of a Topical Sexual Enhancement Cream on the Female Sexual Response and Its Relationship to Clitoral Blood Flow.

OBJECTIVE: The aim of this investigation was to determine, through two Investigational Review Board (IRB)-approved studies, if a new topical vasodilating cream (NTVC; Life Science Enhancement Corporation, Pittsburgh PA) could improve female sexual response. Study I subjectively evaluated sexual female response as accessed by a modification of the Female Intervention Efficacy Index (FIEI). FIEI was developed at the University of California as an immediate outcome measure of medical intervention to treat female sexual dysfunction.1 In Study II, 10 randomly selected positive responders from Study I were subsequently analyzed objectively with clitoral plethysmography in order to determine the effect of the NTVC and placebo on blood flow.2 RESULTS: In the subjective Study I (81 patients ranging in age from 18 to 63), a positive response trend for the NTVC was demonstrated compared to the placebo. In the objective Study II, 10 randomly selected patients who responded positive in Study I were objectively evaluated for response of increased blood flow in the clitoris after application of both the NTVC and placebo. The clitoral blood flow was shown to have increased with statistical significance for the NTVC in all 10 patients compared to the placebo, with the NTVC exhibiting an average 69% increase in clitoral blood flow. CONCLUSIONS: The female sexual response is complex. In the subjective Study I, the NTVC demonstrated positive trends for enhanced lubrication, genital sensation, intercourse, and overall sexual experience. In the objective Study II, 10 of the positive subjective responders from Study I were randomly selected to evaluate their response to the NTVC compared to the placebo. This was done via Doppler plethysmography (DP). All 10 patients demonstrated a statistically significant response rate for increase in clitoral blood flow using the NTVC compared to the placebo, with an average blood flow increase of 69%. This portion of the investigation demonstrates a significant positive end organ response to the NTVC. The positive subjective trends combined with the significant and substantial increase in clitoral blood flow may result in enhanced female sexual satisfaction.

Pharmacologic doses of nicotinamide in the treatment of inflammatory skin conditions: a review.

Various skin disorders with an inflammatory component often have been treated with steroids and/or oral antibiotics. However, long-term use of these agents has drawbacks: steroids may induce numerous serious side effects such as hypertension, immunosuppression, and osteoporosis, and overuse of oral antibiotics may contribute to the development of bacterial resistance, as well as to a host of nuisance side effects such as diarrhea, yeast infections, and photosensitivity. As a result, alternative oral treatments, such as nicotinamide, have been investigated. During the past 50 years, many clinical reports have identified nicotinamide as a beneficial agent in the treatment of a variety of inflammatory skin disorders; what's more, its exceptional safety profile at pharmacologic doses makes it a potentially ideal long-term oral therapy for patients with inflammatory skin diseases. A recent large study evaluating nicotinamide for the treatment of acne or rosacea has confirmed the potential benefits of oral nicotinamide as an alternative approach to managing inflammatory lesions associated with acne vulgaris and acne rosacea. This article reviews the substantial number of reports published over the past 50 years that document the clinical utility and safety of oral and topical formulations of nicotinamide for the treatment of a variety of inflammatory skin conditions.

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

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.