An empirically generated responder definition for rosacea treatment.

OBJECTIVE: The aim of this study was to empirically generate a responder definition for the treatment of papulopustular rosacea. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Comparison of Occlusive and Open Application in a Psoriasis Plaque Test Design, Exemplarily Using Investigations of Mapracorat 0.1% Ointment versus Vehicle and Reference Drugs.

BACKGROUND/AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Patient-reported outcomes of azelaic acid foam 15% for patients with papulopustular rosacea: secondary efficacy results from a randomized, controlled, double-blind, phase 3 trial.

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.

Investigator-reported efficacy of azelaic acid foam 15% in patients with papulopustular rosacea: secondary efficacy outcomes from a randomized, controlled, double-blind, phase 3 trial.

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.

A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea.

Rosacea is a chronic relapsing skin disorder primarily affecting the face. Although its etiology is not well defined, rosacea is associated with immune dysregulation and inflammation potentiated by external factors. These manifestations lead to skin sensitivity and impaired quality of life. Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation. This phase 3 study evaluated the efficacy and safety of AzA in a 15% foam formulation for the treatment of papulopustular rosacea (PPR). Coprimary efficacy end points were treatment success according to investigator global assessment (IGA) and the nominal change in inflammatory lesion count (ILC) from baseline to the end of treatment (EoT). Adverse events (AEs) were evaluated as a measure of safety. The IGA success rate at EoT was significantly greater in the AzA foam group versus vehicle (P<.001; Cochran-Mantel-Haenszel test). Likewise, nominal ILC change at EoT in the AzA foam group showed a significantly greater decrease versus vehicle (P<.001; F test). Drug-related AEs were mainly mild to moderate, cutaneous, and local. Overall, the study results support the efficacy and safety of twice-daily AzA foam 15% in patients with PPR.

[Psoriasis--clinical picture and current therapy]. / Psoriasis: Krankheitsbild und aktuelle Therapie.

This review describes the current knowledge level of epidemiology, genetics and pathogenesis of psoriasis for continuing education purposes. The different clinical appearances and degrees of severity of the illness are portrayed and important associated diseases are depicted. Treatment goals are designated and different therapy forms like topical therapy, phototherapy and classical as well as modem systemic therapies (biologicals) are described.

Localized panniculitis and subsequent lipoatrophy with subcutaneous glatiramer acetate (Copaxone) injection for the treatment of multiple sclerosis.

Glatiramer acetate (copolymer 1, Copaxone) is a mixture of synthetic polypeptides and is used for the treatment of multiple sclerosis. It has been shown to possess beneficial effects in reducing the relapse rate in relapsing-remitting multiple sclerosis. Its main mechanism of action is regarded as a switch of the immune reaction from a T helper (Th)1 to a Th2 cell type. Glatiramer acetate is administered by subcutaneous injection once daily. As described in previous reports, the most common adverse effects are pain, inflammation, and induration at the injection site, occurring in approximately 20-60% of patients. A rare adverse effect is a localized lipoatrophy at the site of injection, which has previously been observed and described in 11 patients. It has been reported that these atrophic areas remain unchanged and localized lipoatrophy may be preceded by a subcutaneous panniculitis. In this article, we describe another case of subcutaneous changes following repeated glatiramer acetate injection, presented as localized panniculitis in the area around the injection sites, in a 46-year-old female patient who was treated with glatiramer acetate for 18 months.