• Reproducibility of Automated and Manual Counting of VSC Producing Organisms

    D. Ricci-Nittel, D.S. Harper, K.A. Baxter, and M.W.B. Araujo, (Pfizer Consumer Healthcare, Morris Plains, NJ USA, Hill Top Research Inc, Miamiville, OH, USA). Poster # 1034 presented at AADR 2006 (Orlando, FL, March 2006).

    Objective: To determine intra- and inter-examiner reproducibility of manual and automated counting of volatile sulfur compound (VSC) producing colonies on OOPS III media (Turng et al., 1997).

    Methods: Human saliva was collected from donors known to have salivary populations of VSC-producing microorganisms, pooled, diluted, and plated on pre-reduced OOPs III medium (20 plates from the common inoculum). Plates were incubated anaerobically to permit growth of dark (VSC-producing) colony forming units (CFUs), and then counted by four trained operators. Plates were counted twice in random order by both manual and automated (ProtoCOL RGB Synbiosis) methods. Plate counts were used to calculate CFU/mL values and Log10 transformed prior to statistical analysis. Standard error of the measurement (SE) was calculated (Araujo et al, 2003). Data analysis included determination of SE for intra- and inter-examiner with both techniques. In addition, the inter-method reproducibility was evaluated to determine whether or not the manual method is a valid alternative to the use of the machine.

    Results: Based on log10 CFU/mL, the mean ± standard deviation (SD) intra-examiner SE was 0.07 ± 0.01 for the automated instrument, and 0.04 ± 0.02 for the manual count. The mean ± SD inter-examiner SE was 0.08 ± 0.01 for the automated method and 0.05± 0.01 for manual. When calculating the inter-method SE, results showed a mean ± SD of 0.09 ± 0.01 for all 4 operators.

    Conclusions: The determination of the SE provides an easy method to measure operator reproducibility when reading plates by manual or automated methods. The reproducibility calculations demonstrated that the examiners are calibrated in all aspects of intra- and inter-reproducibility. Finally, the present study showed that manual or automated techniques produce comparable counts of VSC microorganisms grown on OOPs III agar plates; therefore, either method may be used in research settings.

  • In Vitro Antimicrobial Activity of Vanilla Mint Listerine Antiseptic Mouthrinse

    S. Andreana1, D. Nittel-Ricci1, M.M. Wu1, D.S. Harper1, K.A. Baxter2, 1- Johnson & Johnson Consumer and Personal Products Worldwide, Morris Plains, NJ, USA; 2 - Hill Top Research, Miamiville, OH, USA. Poster # 2205 presented at IADR/AADR 2007 (New Orleans, LA, March 2007).

    Objectives: To evaluate the in vitro antiseptic activity of Vanilla Mint Flavor Listerine ® Antiseptic (VMLA) Mouthrinse.

    Methods: In vitro antimicrobial activity of less intense VMLA mouthrinse was compared to CoolMint Listerine® Mouthrinse (CMLA; positive control) and sterile water (negative control) in an in vitro kill kinetic critical time assay, in accordance with the relevant ADA Guideline. The products were tested against a panel of twenty representative oral and opportunistically infectious microorganisms, including species of: Actinomyces, Campylobacter, Candida, Capnocytophaga, Eikenella, Fusobacterium, Actinobacillus, Lactobacillus, Leptotrichia, Porphyromonas, Prevotella, Pseudomonas, Staphylococcus, and Streptococcus. Each organism was grown under appropriate conditions, and subsequently exposed to the mouth rinses at a ratio of 1:9 v/v for 0.5, 1.0, and 2.0 minutes. At each time point an aliquot of 100 µl was placed in a neutralizing nutrient broth to inactivate the antimicrobial activity of the test solution and permit surviving organisms to grow. Turbidity was used as the end point. The shortest exposure time that resulted in no turbidity was considered the critical kill time. In separate tests, fetal bovine serum (FBS) was added to simulate biological fluids.

    Results: For all twenty microorganisms, VMLA and CMLA demonstrated a critical kill time of <0.5 minutes, both in the presence and absence of serum. Sterile water did not show any antimicrobial activity.

    Conclusions: VMLA and CMLA mouthrinses exhibit antimicrobial activity versus representative oral microorganisms.

  • Randomized Clinical Study Comparing Compeed Cold Sore Patch to Acyclovir Cream 5% in the Treatment of Herpes Simplex Labialis

    Tony Karlsmark, MD, MDSc1; J. John Goodman, MD2; Yorik Drouault, MD3; Laura Lufrano, RPh4; Gordon W. Pledger, PhD5; and the Cold Sore Study Group. 1Bispebjerg Hospital, Copenhagen, Denmark; 2Hill Top Research, West Palm Beach, Florida; 3Dermexpert, Paris, France; 4Johnson & Johnson, Skillman, New Jersey; 5Johnson < Johnson consultant statistician, Hamilton, Texas. Poster presented at the 14th Meeting of the International Herpes Management Forum - Oct 10-11, 2007 (Croatia).

    Background: Hydrocolloid technology has been proven effective in treating dermal wounds. A previous study showed that a newly developed thin hydrocolloid patch [Compeed® cold sore patch (CSP)] provided multiple wound healing benefits across all stages of a herpes simplex labialis (HSL) outbreak.

    Methods: An assessment of CSP efficacy and safety was conducted in an international, multi-centre, assessor-blinded study, which enrolled 728 subjects with a history of recurrent HSL. Of these, 351 experienced an HSL outbreak and were randomized to use CSP (n = 179) or acyclovir cream 5% (n = 172) at the onset of symptoms until the lesion healed, for a maximum of 10 days. The primary end point was the subject’s global assessment of therapy (SGAT; 0–10 scale; 0 = no response, 10 = excellent response). Multiple secondary end points included clinician-assessed healing time and subject assessment of lesion protection, noticeability and social embarrassment.

    Results: CSP and acyclovir were highly effective (mean SGAT = 7.89 and 8.00, respectively), with no significant difference observed (P = 0.65). The difference in healing times between products was not significant (median, 7.57 days with CSP vs. 7.03 days with acyclovir, P = 0.37). Both treatments were well tolerated.

    Conclusion: CSP using hydrocolloid technology provides an efficacious and safe alternative to topical antivirals in treating HSL as a wound while affording additional immediate benefits of wound protection, discretion and relief of social embarrassment.

  • Clinical Strategies for Determining Effectiveness of Various Antiaging Skin Care Products

    Nalini Kaul and Elsie Kohoot, Hill Top Research, Poster No. P211, American Academy of Dermatology, (San Antonio, TX, February 2008).

    The demand for anti-aging skin regimens is at an all-time high. Anti-aging facial skin care products (lotions and creams) work on facial lines, crow’s feet, fine lines, and wrinkles. Other concerns include skin surface dryness, roughness, dullness, laxity, skin tone, hyper and hypo pigmentation and overall appearance of the skin. Antioxidants, vitamins, omega 3 fatty acids, alpha lipoic acid, and neuropeptides are becoming increasingly incorporated into facial creams and lotions for improved clinical performance.

    Our primary aim was to capture photo-aging characteristics and provide a testing strategy for anti-aging facial regimens by checking for improvement with these products. Current strategies involve enrollment of healthy female subjects (35-60 years) who give signed informed consent. Subjects are screened for extent of photo damage, and those with mild to moderate overall photo damage meet study criteria and are enrolled in clinical trials from 4-12 weeks.

    Subjects in the clinical trial presented here were asked to use the antioxidant rich anti-aging regimen twice daily for the entire duration of the study. Measurements included clinical visual assessments by a blinded expert evaluator, subjective assessments, silicon replicas, and digital photographs at baseline, midpoint and at the end of the clinical trials. Our results, based on and supported by scientific testing and clinical assessments, provide insight into product efficacy, safety and consumer acceptance by the tracking of photo-aging skin characteristic changes.

  • Skin Moisturizers: Therapeutic Potential and Preventative Maintenance of Dry Skin

    Nalini Kaul, Michael Sinaisky and Elsie Kohoot, Hill Top Research, Poster No. P615, American Academy of Dermatology, (San Antonio, TX, February 2008).

  • Examination of the Inclusion of UV Wavelengths 400nm to 700nm (Visible Light) in Photosafety Testing

    Dr. Sabine Teske, Jeffrey Berg, Stacey Risk, Dr. Robert Sayre, Dr. John C. Dowdy Hill Top Research, Rapid Precision Testing Laboratories Poster presented at the SCC Florida Sunscreen Symposium, Orlando, FL, September, 2007 and also at the Society of Cosmetic Chemists' Annual Scientific Meeting & Technology Showcase. December, 2007.

    Both the European Agency for the Evaluation of Medicinal Products (EMEA) and the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) provide guidance for photo-safety testing. Both documents are intended to guide the industry in determining if a product should be tested for photo-irritation and/or photo-allergy and, if so, which test is most appropriate. Although in vitro methods are available and are an essential tool in determining preclinical and light absorption data, clinical testing is often more predictive of potential phototoxic effects in humans. Clinical tests most often assess photo-irritation using the photo-toxicity method and photosensitization using the photoallergy method. Typically, standard methods of UV exposure are conducted using a solar simulator which filters out the majority of visible light, thus leaving only UVA and/or UVB. As indicated in both guidelines, absorption not only occurs in the UVA (320-400nm) and UVB (290-320nm) ranges, but may also occur in the visible light range (400-700nm). Therefore, it is important for the industry to understand the potential interaction of visible light with drug, household, and cosmetic products and the impact on human safety, the history of test methods using visible light, and how visible light can be incorporated in future photo-safety testing in a clinical setting.