<b><i>Background/Aims:</i></b> Psoriasis plaque tests (PPTs) are important tools in the early phases of antipsoriatic drug development. Two distinct PPT design variants (open vs. occluded drug application) are commonly used, but no previous work has aimed to directly compare and contrast their performance. <b><i>Methods:</i></b> We compared the antipsoriatic efficacy of mapracorat 0.1% ointment and reference drugs reported in 2 separate studies, representing open and occluded PPT designs. The drug effect size was measured by sonography (mean change in echo-poor band thickness), chromametry, and standardized clinical assessment. <b><i>Results:</i></b> Antipsoriatic effects were detectable for the study drugs in both occluded and open PPTs. Differences between the potency of antipsoriatic drugs and vehicle were observable. The total antipsoriatic effect size appeared to be higher in the occluded PPT than the open PPT, despite the shorter treatment duration (2 vs. 4 weeks). Effect dynamics over time revealed greater differences between some study drugs in the open PPT compared to the occluded PPT. <b><i>Conclusion:</i></b> Taking the higher technical challenges for the open PPT into account, we recommend the occluded PPT as a standard screening setting in early drug development. In special cases, considering certain drug aspects or study objectives that would require procedural adaptations, an open PPT could be the better-suited design. Finally, both PPT models show clear advantages: classification as phase I studies, small number of psoriatic subjects, relatively short study duration, excellent discrimination between compounds and concentrations, parallel measurement of treatment response, and go/no go decisions very early in clinical development.
Papulopustular rosacea (PPR) is characterized by centrofacial papules and pustules commonly associated with erythema. To compare investigator-reported efficacy outcomes for azelaic acid (AzA) foam 15% versus vehicle foam in PPR, a randomized, vehicle-controlled, double-blind phase 3 clinical trial was conducted at 48 US sites. Participants received AzA foam or vehicle foam for 12 weeks. Secondary efficacy outcomes included change in inflammatory lesion count (ILC), therapeutic response rate according to investigator global assessment (IGA), and change in erythema rating. This study was comprised of 961 participants with PPR. The results support the therapeutic superiority of AzA foam over vehicle foam.
Wir beschreiben die erworbene, reaktiv perforierende Dermatose (RPD) anhand von 15 Patienten, die zwischen 2003 und 2006 stationär in der Dermatologischen Klinik des Klinikums Bremen-Mitte behandelt wurden. Besonderes Augenmerk gilt dabei der Assoziation der RPD mit internistischen Erkrankungen und der Medikation der oft multimorbiden Patienten. Dargestellt werden unsere Erfahrungen mit verschiedenen therapeutischen Optionen.
Patient-reported treatment outcomes are important for evaluating the impact of drug therapies on patient experience. A randomized, double-blind, vehicle-controlled, parallel-group, multicenter, phase 3 study was conducted in 961 participants to assess patient perception of efficacy, utility, and effect on quality of life (QOL) of an azelaic acid (AzA) 15% foam formulation for the treatment of papulopustular rosacea (PPR). Secondary end points included patient-reported global assessment of treatment response, global assessment of tolerability, and opinion on cosmetic acceptability and practicability of product use. Quality of life assessments included the Dermatology Quality of Life Index (DLQI) and Rosacea Quality of Life Index (RosaQOL). Self-reported global assessment of treatment response favored AzA foam over vehicle foam (P<.001), with 57.2% of the AzA foam group reporting excellent or good improvement versus 44.7% in the vehicle foam group. Tolerability was rated excellent or good in 67.8% of the AzA foam group versus 78.2% of the vehicle foam group. Mean overall DLQI scores at end of treatment (EoT) were improved (P=.018) in favor of the AzA foam group compared with the vehicle foam group. Both treatment groups showed improvements in RosaQOL. Treatment with AzA foam was associated with improved QOL and meaningful reductions in the patient-perceived burden of PPR, which correlates with earlier reported primary end points of this study and supports the inclusion of patient perspectives in studies evaluating the effects of topical dermatologic treatments.
Acne in the adult female often presents as a chronic condition that can have a considerable negative psychological, social and emotional impact on the affected individual. Estimated prevalence rates of adult female acne vary widely according to study type. Case reports and clinical examinations estimate the prevalence of clinical acne at 10-12%, while survey estimates of physiological disease states are as high as 54%. Two subtypes of adult female acne may be defined according to time of onset: 'persistent' and 'late-onset', accounting for approximately 80 and 20% of cases, respectively. Postadolescent acne is generally mild-to-moderate in severity and presents with more inflammatory lesions and fewer comedones compared to adolescent acne. Furthermore, the impact of acne on the quality of life is often greater in adult females than in younger individuals. Despite these important differences, the key principles of acne treatment in the adult female do not differ significantly from those of other age groups. However, specific characteristics relating to the adult female should be considered when selecting a treatment regimen.
The aim of this study was to empirically generate a responder definition for the treatment of papulopustular rosacea.A total of 8 multicenter clinical studies on patients with papulopustular facial rosacea were analyzed. All patients were treated with azelaic acid and/or comparator treatments. The severity of rosacea was described by the Investigator Global Assessment (IGA) and the number of lesions. Patients with the IGA score of "clear/minimal" were considered as responders, and those staying in the range of IGA "mild to severe" as nonresponders. The respective number of lesions was determined.A total of 2,748 patients providing 12,410 measurements were included. After treatment, responders showed 2.23±2.48 lesions (median 2 lesions [0-3]), and nonresponders showed 13.74±10.40 lesions (median 12 lesions [6-18]). The optimal cutoff point between both groups was 5.69 lesions.The calculated cutoff point of 5.69 lesions allows discrimination of responders (5 or less remaining lesions) and nonresponders (6 or more remaining lesions) of therapeutic interventions in rosacea.
