The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes

achieved by 27% of subjects in the CalcipF group and 16% in the vehicle group (P=0.016), with 26.9% of subjects rated as ISGA mild at baseline.27 The percent of mild severity subjects at baseline can influence study outcomes as differentiation between topical products by ISGA assessments is primarily revealed among subjects with greater severity of disease. CalcipF-treated subjects showed better response rates than subjects treated with vehicle foam for most secondary outcomes, including ratings of erythema, scaling, and plaque thickness of the baseline target lesion, and assessment of response in subjects with a baseline ISGA rating of moderate severity.²⁷ Figures 1 and 2 depict individual responses by EOT in subjects treated with CalcipF applied BID as monotherapy for body plaque psoriasis during the RCTs.CalcipF was safe and well-tolerated with an overall rate of adverse events (AEs) similar to those noted in the vehicle group.²⁷ Application-site reactions (ASRs) occurred in approximately 1–2% of subjects in each group. Treatment was discontinued because of AEs in approximately 2% of subjects in both groups, with most due to ASRs. No concerning systemic safety signals emerged in either study group.²⁷ Scalp Psoriasis An 8-week RCT was completed in subjects greater than equal to 12 years of age treated with CalcipF BID (n=181) or vehicle foam BID (n=182) for scalp psoriasis of moderate ISGA severity affecting greater than equal to 10% of scalp surface area.³⁸ Both genders were well represented (60% male; 40% female). The primary efficacy endpoint was percent subjects achieving ISGA clear or almost clear at EOT (week 8), which automatically required greater than equal to 2-grade improvement.Primary endpoint success was achieved by 41% in the CalcipF group and 24% in the vehicle group (P equals 0.001).³⁸ No systemic safety signals were observed. The incidence of ASRs in both study groups were similar to those observed in the RCTs with body psoriasis. Application site pain (ie, stinging, burning), pruritus, and erythema occurred in 4%, 4%, and 3% of CalcipF-treated subjects, and in 3%, 4%, and 0% of vehicle-treated subjects, respectively.38 Figure 3 shows an example of a subject treated with CalcipF BID for scalp psoriasis (data on file).Tazarotene 0.1% Foam for Acne Vulgaris Tazarotene (Taz) is a topical retinoid, available initially as both 0.1% and 0.05% gel and cream formulations, that has been evaluated extensively for treatment of acne vulgaris (AV) and plaque psoriasis.^34,39,40 After application to skin, Taz is rapidly converted to tazarotenic acid, which is biologically active via binding to specific retinoic acid receptors, resulting in several suggested modes of action.^34,39 These include regulation of cellular proliferation, differentiation and dermal matrix degradation, and modulation of various pathways and signals involved in cutaneous inflammation.^34,39,40 More recently, Taz 0.1% has been formulated in an aqueous-based foam containing non-comedogenic light mineral oil, devoid of ethanol, fragrances, propylene glycol, and parabens, that has been shown to be effective for once daily (QD) treatment for AV of the face and/or upper trunk.^24,33 Lower systemic exposure of tazarotenic acid was also shown in a comparative bioavailability study after widespread application of Taz foam to face, chest, upper back, and shoulders as compared to Taz gel.²⁶ In the pivotal studies, TazF was packaged in aluminum cans pressurized with a propane/butane propellant; the vehicle foam was packaged identically except for absence of the active ingredient.^25,33 Acne Vulgaris Taz 0.1% foam (TazF) is FDA-approved for topical treatment of AV in patients greater than equal to 12 years of age; a thin layer is to be applied QD to the face and/or upper trunk in the evening, with concomitant use of moisturizer if needed.^25,33 Two 12-week RCTs were completed in subjects with baseline Investigator Global Assessment