Abstract
Background: Dandruff and seborrheic dermatitis (D/SD) are common and troublesome scalp conditions with the primary signs and symptoms being presence of skin flakes, pruritus, a tight feeling, and sometimes erythema. Aim: To demonstrate the reliability and relevance of a clinical model for the assessment of therapeutic efficacy of a treatment using the Adherent Scalp Flaking Score (ASFS) method to quantitate the flaking severity. Methods: Six randomized, double-blind, parallel design studies were conducted in either North America or Asia with subjects suffering from dandruff using the ASFS grading method before and after a 3-week test product treatment period. Results: Treatment with a commercial potentiated 1% zinc pyrithione (ZPT) shampoo resulted in statistically significant (p < 0.0001) improvements in total ASFS compared with the placebo cosmetic shampoo. Results were consistent across all studies, geographies, and product usage protocols (controlled on-site versus home use conditions), and were associated with statistically significant improvements in self-perception of scalp condition. Conclusion: The ASFS-based clinical model was demonstrated to be a reliable and proven methodology to assess the effectiveness of widely used anti-dandruff treatments. The results are consistent with patient self-assessments, establishing this methodology as relevant to patient perception of product benefits.
Acknowledgements
The authors thank R. Helmchen for technical and editorial assistance with manuscript preparation. This study was funded by The Procter and Gamble Company.