A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis.

BACKGROUND: Replicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD). Prior studies evaluating Modified Vaccinia Ankara virus (MVA), a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers. OBJECTIVE: This Phase II study compared the safety and immunogenicity of MVA enrolling groups of 350 subjects with AD (SCORAD ≤ 30) and 282 healthy subjects. METHODS: Subjects were vaccinated twice with MVA, each dose given subcutaneously 4 weeks apart. Adverse events, cardiac parameters, and the development of vaccinia virus humoral immune responses were monitored. RESULTS: The overall safety of the vaccine was similar in both groups. Adverse events affecting skin were experienced significantly more often in subjects with AD, but the majority of these events were mild to moderate in intensity. Seroconversion rates and geometric mean titers for total and neutralizing vaccinia-specific antibodies in the AD group were non-inferior compared to the healthy subjects. LIMITATIONS: The size of the study population limited the detection of serious adverse events occurring at a frequency less than 1%. CONCLUSION: MVA has a favorable safety profile and the ability to elicit vaccinia-specific immune responses in subjects with AD. TRIAL REGISTRATION: ClinicalTrials.gov NCT00316602.

Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations.

BACKGROUND: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. OBJECTIVE: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations. METHODS: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies. RESULTS: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator's global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity. CONCLUSION: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.

Different treatment outcomes with different formulations of clobetasol propionate 0.05% for the treatment of plaque psoriasis.

Two advanced formulations of clobetasol propionate (CP) 0.05% (Clobex Spray; Galderma Laboratories, L.P., Fort Worth, TX, USA and Olux Foam; Stiefel/Connetics Corp., Coral Gables, FL, USA) were compared in a study of 77 randomized patients with moderate to severe plaque psoriasis. At the end of the treatment period (2 weeks for CP foam or up to 4 weeks for CP spray per product labeling), patients treated with CP spray had a median 64% reduction in affected body surface area (BSA) compared to a median 25% reduction in patients treated with the CP foam (p = 0.004). Also at the end of the treatment period, 22% of CP spray-treated patients were completely clear compared to 5% of CP foam-treated patients (p = 0.04). Improvements in quality of life as determined by the Dermatology Life Quality Index were statistically significantly greater at all time points for patients treated with CP spray compared to patients treated with CP foam (p<0.04 for all). The majority of adverse events for both products were mild in severity. Thus, while both of these formulations contain the same active ingredient at the same concentration, differences in their efficacy were observed when each treatment was used within its approved labeling guidelines.

Aphthous ulcers associated with imiquimod and the treatment of actinic cheilitis.

Our case series report is the first documented depiction of the appearance of aphthous ulcers secondary to imiquimod application. This case series presentation discusses the underlying pathophysiology of aphthous ulcer development and imiquimod therapy in terms of the stimulation of proinflammatory cytokines, such as tumor necrosis factor alpha (TNF-alpha). The literature review suggests more than just a mere coincidence for the development of aphthous ulcers subsequent to the treatment of actinic cheilitis with imiquimod application.