ABSTRACT: BACKGROUND: Optical coherence tomography (OCT) is a technique that enables real-time in-vivo examination of tissue. This technology provides the clinician with the potential to use a non-invasive tool in the identification and diagnosis of many skin lesions. However, the diagnostic features of basal cell carcinoma have not yet been described with comparison to their histopathology.
OBJECTIVES: To identify and describe key features of basal cell carcinoma (BCC) and its subtypes as they present in multi-beam Swept Source – OCT (MSS-OCT), and to correlate those against conventional histopathology.
METHODS: A total of 40 lesions were assessed by MSS-OCT prior to biopsy. 60-slice OCT images of the lesions were obtained and correlated with histology sections taken in the same plane. OCT scans were assessed retrospectively by a panel to determine the OCT criteria for BCC and its subtypes.
RESULTS: The following diagnostic criteria were identified: hyporeflective ovoid structures (40/40), dark halo boundaries (38/40), epidermal thinning (28/40), and collagen compression (14/40). Lesional tissue also showed a destruction of layers when compared to the surrounding normal tissue. In addition to the shared criteria, other subtypes showed distinct diagnostic criteria.
CONCLUSION: With its higher sensitivity, using MSS-OCT allowed for non-invasive, accurate identification of the key diagnostic features of BCC and its subtypes with high correlation to the histopathologic features found with biopsy.
J Drugs Dermatol. 2016;15(5):545-550. more
ABSTRACT: BACKGROUND: Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of “none” for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.
J Drugs Dermatol. 2016;15(5):553-561. more
ABSTRACT: INTRODUCTION: We evaluated post hoc the relationship between Humira® (adalimumab) therapy and high-sensitivity C-reactive protein (hs-CRP) levels in patients with moderate-to-severe hand and/or foot psoriasis from the 16-week placebo-controlled period of REACH.
METHODS: REACH was a phase 4, multicenter, randomized, double-blind trial, evaluating adalimumab treatment for patients with psoriasis of the hands and/or feet. Adults were randomized 2:1 to adalimumab 40 mg every other week (following 80 mg at week 0) or matching placebo from weeks 1 to 16, followed by a 12-week, open-label extension. In this post hoc analysis, changes in hs-CRP were reported as observed from baseline to week 16.
RESULTS: Of the 72 patients (23 placebo, 49 adalimumab) who participated in REACH, 63 (19 placebo, 44 adalimumab) with hs-CRP measurements at baseline and at week 16 were included in this analysis. Baseline median hs-CRP values were 1.6 mg/L (placebo) and 2.2 mg/L (adalimumab), and were 3 times higher for patients with, as compared with those without, psoriatic arthritis (5.45 vs 1.8 mg/L). At week 16, the adalimumab group showed greater improvements (median reduction) from baseline than the placebo group in hs-CRP overall (−0.55 vs +0.10 mg/L), regardless of achievement of PGA of the hands and/or feet (hfPGA) 0 or 1 at week 16 (−0.80 vs 0 mg/L for patients who achieved hfPGA 0/1; −0.40 vs +0.30 mg/L, patients who did not achieve hfPGA 0/1), baseline psoriatic arthritis history (−2.35 mg/L with history [adalimumab group; no history for placebo group]; −0.40 vs +0.10 mg/L without history), and body mass index (BMI) category (defined by median BMI) (−0.80 vs +0.20 mg/L for BMI <30.28 kg/m2; −0.40 vs 0 mg/L for BMI ≥30.28 kg/m2).
CONCLUSION: Treatment with adalimumab 40 mg every other week resulted in greater overall reductions in hs-CRP levels among patients in this post hoc analysis, compared with placebo at 16 weeks regardless of baseline characteristics.
ClinicalTrials.gov Registry for REACH: NCT00735787
J Drugs Dermatol. 2016;15(5):562-566. more