• Creating, Implementing, and Evaluating a Quality Assurance (QA) Training Program: Use of Individualized Training Plans (ITPs).

    Godfrey, B.; Knight-Bohnhoff, K., PhD, RN; Myers, J. Hill Top Research, St. Petersburg, Florida. Presented at the Society of Quality Assurance Annual Meeting. (Phoenix, AZ, April, 2006).

    Creating, implementing, and evaluating a training program for Quality Assurance (QA) professionals is critical to the success of any Quality Assurance Unit (QAU). Given the ever-increasing complexity of clinical trials, QA Auditors must complete individualized training programs based on their current levels of expertise. This ensures that they acquire practical knowledge related to current QA methodologies as well as regulations and quality standards. Hill Top Research has designed and implemented an Individual Training Plan (ITP) for each QA Associate. Presented here are the elements of the ITP, the implementation process, and the steps to evaluate the training program.

  • Skin Statistics: Basic and Applied

    J. Bowman. Presented at the New Jersey Skin Club Seminar. Rutgers University, Busch Campus, Piscataway, New Jersey. September 25, 2007.

  • A Clinical Study to Evaluate The Efficacy of Two Marketed Zinc Oxide-Based Diaper Rash Ointments in Children with Diaper Dermatitis

    W. Michael Brown, MD, FAAP1, Jeffrey E. Berg, BS1, Qing Li, MD, PhD2, Bruce E. Kohut, DMD2, 1 - Health & Personal Care, Hill Top Research, St. Petersburg, FL, USA, 2 - Global Medical Affairs & Clinical Research, Pfizer Consumer Healthcare, Morris Plains, NJ, USA. Presented at The Fall Clinical Dermatology Conference, October 6-9, 2006. Las Vegas, NV.

    The objective of this study was to evaluate whether two marketed topical zinc oxide-based diaper rash products provided relief of diaper dermatitis after 12 and 24 hours of treatment.

    This was an evaluator-blinded, two-arm, randomized, parallel trial conducted on children 2-36 months old and wearing diapers 24 hours a day. Severity of diaper dermatitis was assessed by a trained skin evaluator and parents/guardians after 12 and 24 hours of treatment. Subjects were enrolled and randomized if they received an overall severity score of mild/moderate or higher at baseline by the trained evaluator. Investigational products (IPs) were applied following a gentle cleansing of the diaper zone at every diaper change and following bathing of the subject.

    Results of the analyses of the five anatomic areas and overall severity score by the evaluator’s assessments, and parent/guardian’s assessments all indicated that both products were significantly effective (P < 0.05) in relieving diaper dermatitis after 12 and 24 hours of treatment.

  • A Review of Skin Irritation Protocols for the Evaluation of Skin Irritation Potential

    W. Billhimer. Presentation given at the Society of Cosmetic Chemists' Annual Scientific Meeting & Technology Showcase. December 7, 2007.

    All substances possess some potential irritancy which must be fully evaluated to ensure that marketed products are not unacceptably irritating. With the wide range of ingredients and formulations to be evaluated, adequate thought and preparation must go into the evaluation strategy. In patch testing, prolonged contact under occlusion is expected to reveal whether a substance has demonstrable irritancy potential. However, its potential under use conditions may not be evident. By spreading the evaluation over a spectrum of exposure conditions, a truer evaluation of irritation potential is obtained than by merely taking a single reading at an arbitrary point. Rigorous product assessment is critical in the product development process to assure safety and consumer acceptance.