Assessing therapeutic effectiveness of scalp treatments for dandruff and seborrheic dermatitis, part 1: a reliable and relevant method based on the adherent scalp flaking score (ASFS).

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.

Assessing therapeutic effectiveness of scalp treatments for dandruff and seborrheic dermatitis, part 2: the impact of gender and ethnicity on efficacy.

BACKGROUND: Dandruff and seborrheic dermatitis (D/SD) are common and troublesome scalp conditions that affect individuals independent of gender or ethnicity. AIM: To evaluate whether population gender or ethnic origins impact the magnitude of anti-dandruff therapeutic benefit obtained from use of a potentiated zinc pyrithione shampoo treatment. METHODS: A retrospective evaluation of anti-dandruff clinical data covering a single-product technology was conducted to assess whether statistically meaningful differences were observed for gender or ethnic sub-populations. An analysis of covariance was performed on the pooled subject-level data. RESULTS: Meta-analysis of clinical data involving 1114 subjects from seven trials demonstrated the lack of statistically significant impact of gender on flaking or selected biomarker measures. Similarly, a smaller population chosen to assess ethnicity demonstrated the lack of differences between Asian and Caucasian clinical sub-population responses (flaking severity). CONCLUSION: Through the use of both expert symptom grading and objective biomarker assessments, therapeutic efficacy of a potentiated zinc pyrithione shampoo was found to be independent of gender and ethnicity, being consistent with the lack of functional differences in skin from these populations.

Epidermal changes associated with symptomatic resolution of dandruff: biomarkers of scalp health.

BACKGROUND: Dandruff is a common scalp condition characterized by flakes, pruritus and sometimes mild erythema. These symptoms reflect underlying histopathologic and biochemical events that must be reversed if treatment is to be effective. OBJECTIVES: This study aimed to better characterize the state of the epidermis in dandruff and to determine how a defined set of skin surface biomarkers of this state change during a successful course of treatment with a potentiated zinc pyrithione (ZPT) shampoo. METHODS: A population of dandruff sufferers was treated for 3 weeks with a commercial ZPT shampoo or a non-medicated product, and the effect of treatment on adherent scalp flake (ASF) scores was evaluated. Biopsies were taken from lesional sites at baseline and at the end of the study for histomorphometric and histopathologic analysis. Stratum corneum (SC) samples were likewise obtained for evaluation of biochemical markers of inflammation (IL-1α, IL-1RA, IL-8) and barrier integrity (keratin 1, 10, 11; involucrin; SC lipids; human serum albumin). The biomarker profile was evaluated first by comparison with that in non-dandruff subjects at baseline, and then to determine whether any treatment-induced changes were correlated with reductions in flaking in dandruff sufferers. RESULTS: Taken together, our studies showed that treatment with the ZPT shampoo led to an improvement in the overall scalp condition as assessed by the resolution of flaking, reduction in epidermal thickness and inflammatory biomarkers, and a dramatic improvement in biomarkers of epidermal barrier integrity. CONCLUSIONS: The combination of biomarkers examined appears to be a good overall descriptor of the health of the scalp in dandruff, and changes in these biomarkers track with tissue-level events that underlie clinical efficacy in the treatment of dandruff by ZPT shampoo. For the first time, we demonstrate a set of tools that extend beyond flaking scores to provide insight into specific biological changes occurring on the scalp to enable an objective assessment of scalp health.

The effects of a daily facial lotion containing vitamins B3 and E and provitamin B5 on the facial skin of Indian women: a randomized, double-blind trial.

BACKGROUND: The B vitamins niacinamide and panthenol have been shown to reduce many signs of skin aging, including hyperpigmentation and redness. AIMS: To measure the facial skin effects in Indian women of the daily use of a lotion containing niacinamide, panthenol, and tocopherol acetate using quantitative image analysis. METHODS: Adult women 30-60 years of age with epidermal hyperpigmentation were recruited in Mumbai and randomly assigned to apply a test or control lotion to the face daily for 10 weeks. Effects on skin tone were measured using an image capturing system and associated software. Skin texture was assessed by expert graders. Barrier function was evaluated by transepithelial water loss measurements. Subjects and evaluators were blinded to the product assignment. RESULTS: Of 246 women randomized to treatment, 207 (84%) completed the study. Women who used the test lotion experienced significantly reduced appearance of hyperpigmentation, improved skin tone evenness, appearance of lightening of skin, and positive effects on skin texture. Improvements versus control were seen as early as 6 weeks. The test lotion was well tolerated. The most common adverse event was a transient, mild burning sensation. CONCLUSIONS: Daily use of a facial lotion containing niacinamide, panthenol, and tocopheryl acetate improved skin tone and texture and was well tolerated in Indian women with facial signs of aging.

Gene expression profiles during in vivo human rhinovirus infection: insights into the host response.

RATIONALE: Human rhinovirus infections cause colds and trigger exacerbations of lower airway diseases. OBJECTIVES: To define changes in gene expression profiles during in vivo rhinovirus infections. METHODS: Nasal epithelial scrapings were obtained before and during experimental rhinovirus infection, and gene expression was evaluated by microarray. Naturally acquired rhinovirus infections, cultured human epithelial cells, and short interfering RNA knockdown were used to further evaluate the role of viperin in rhinovirus infections. MEASUREMENTS AND MAIN RESULTS: Symptom scores and viral titers were measured in subjects inoculated with rhinovirus or sham control, and changes in gene expression were assessed 8 and 48 hours after inoculation. Real-time reverse transcription-polymerase chain reaction for viperin and rhinoviruses was used in naturally acquired infections, and viperin mRNA levels and viral titers were measured in cultured cells. Rhinovirus-induced changes in gene expression were not observed 8 hours after viral infection, but 11,887 gene transcripts were significantly altered in scrapings obtained 2 days postinoculation. Major groups of up-regulated genes included chemokines, signaling molecules, interferon-responsive genes, and antivirals. Viperin expression was further examined and also was increased in naturally acquired rhinovirus infections, as well as in cultured human epithelial cells infected with intact, but not replication-deficient, rhinovirus. Knockdown of viperin with short interfering RNA increased rhinovirus replication in infected epithelial cells. CONCLUSIONS: Rhinovirus infection significantly alters the expression of many genes associated with the immune response, including chemokines and antivirals. The data obtained provide insights into the host response to rhinovirus infection and identify potential novel targets for further evaluation.

Inhibition of rhinovirus replication in vitro and in vivo by acid-buffered saline.

Human rhinoviruses (HRVs) are quite sensitive to low pH. To determine whether this characteristic might be a therapeutic target, we evaluated the sensitivity of HRV to low-pH buffers in vitro and in vivo. Our findings confirm that low pH inhibited replication of most HRVs and reduced the replication of influenza virus. Preliminary experiments verified that the surface pH of the human nasopharynx could be transiently lowered to pH approximately 4.0 by topical administration of citrate/phosphate (CP) buffers, which was well tolerated. In a pilot experimental colds study, intranasal administration of CP buffer, compared with normal saline, reduced viral shedding by 1 log unit (10(3) vs. 10(4) 50% tissue culture infective dose/mL; P<.01), although respiratory symptoms were not significantly reduced. These findings demonstrate that low-pH buffers have antiviral activity in vivo and suggest that a larger clinical trial is warranted to determine whether this approach could reduce rates of viral transmission.