Capturing total steroid burden in patients with atopic dermatitis and asthma.

Background: The cumulative burden of cutaneous, inhaled, intranasal and systemic corticosteroids (CS) in individual patients should be routinely assessed. Methods: Our monitoring tool collected data on CS type, potency, frequency, side effects, interventions and patient counseling in every encounter. Results: 82 AD patients had 151 encounters. Severe AD had more side effects than those without (68.18% vs 41.67% respectively, P < 0.0333). Those with higher TSB had more side effects overall (p < 0.0493). There was also significant positive correlation with higher TSB and the overall number of side effects (p < 0.0116). 101 asthmatics had 193 encounters. Over 50% of asthma patients had other CS. Severe asthmatics had more side effects than those without (62.5% vs 20.8%, p < 0.0001). Patients with higher TSB had more side effects overall (p < 0.0001). There was also significant positive correlation with a higher TSB and the overall number of side effects (p < 0.0001). 80% of AD and 90% of asthma patients were satisfied with the counseling. The EHR in AD and asthma resulted in counseling in 89% and 93% respectively and real-time intervention in 27.8% and 3% respectively. Although patients with side effects had more dose adjustments, those without side effects also warranted adjustments. Physician surveys demonstrated improved satisfaction with the EHR tool over time, and minimal impact on visit time. Conclusion: The utilization of our EHR monitoring tool allows for the identification and tracking of TSB in patients, associated side effects and leads to real-time physician intervention.

Noninvasive Long-term Monitoring of Actinic Keratosis and Field Cancerization Following Treatment with Ingenol Mebutate Gel 0.015.

OBJECTIVE: To determine whether actinic keratosis and photodamaged perilesional areas (field cancerization) treated successfully with topical ingenol mebutate gel 0.015% remained clear one year later, and to treat actinic keratosis and perilesional skin not treated one year earlier. DESIGN: Single-center, single-arm, open-label extension of an original clinical study completed one year earlier. SETTING: An outpatient clinic. PARTICIPANTS: Fifteen of the original 28 study patients enrolled in and who completed the extension phase. MEASUREMENTS: All treated and untreated lesions in the original study were evaluated clinically, dermoscopically, and with optical coherence tomography at Day 0 of the extension study. Previously untreated lesions were then treated with ingenol mebutate gel 0.015% for three days and reevaluated at Day 60. RESULTS: There was no significant increase in actinic keratoses over one year. The majority of actinic keratoses not treated in the original study were still present at the beginning of the extension study. Following treatment, 69 percent of these lesions cleared by Day 60 of the extension study, which was not significantly different from the 79 percent clearance observed in the original study. CONCLUSION: Ingenol mebutate 0.015% maintained clearance of lesions treated one year earlier. Optical coherence therapy demonstrated its reliability as a noninvasive mode of diagnosis for actinic keratosis as well as actinic damage in the surrounding areas of field cancerization. Optical coherence therapy also showed that previously untreated lesions exhibited similar clearance rates once treated with the medication.

Defining Field Cancerization of the Skin Using Noninvasive Optical Coherence Tomography Imaging to Detect and Monitor Actinic Keratosis in Ingenol Mebutate 0.015%- Treated Patients.

OBJECTIVE: The objective of this study was to assess the ability of optical coherence tomography to detect clinical and subclinical actinic keratoses confirmed by histopathology. The efficacy of ingenol mebutate treatment of actinic keratosis was also evaluated using optical coherence tomography, and correlation of treatment efficacy with severity of local skin reactions was determined. DESIGN: Single-arm, open-label, split-face study. SETTING: Hospital outpatient clinic. PARTICIPANTS: Male subjects (N=30) with seven actinic keratoses. MEASUREMENTS: A suspected actinic keratosis and the normal-appearing, perilesional skin were imaged, biopsied for histopathologic analysis, and the results compared with the clinical and a blinded optical coherence tomography diagnosis. Treatment with ingenol mebutate gel 0.015% was randomly administered to three clinically suspected actinic keratoses and the perilesional skin; three additional, suspected actinic keratoses lesions and perilesional areas were left untreated. Clinical and optical coherence tomography images were obtained for all lesions. Severity of local skin reactions was recorded to evaluate the relationship between local skin reaction and treatment effect. RESULTS: Optical coherence tomography analysis had a 100-percent (28/28) correlation with the clinical diagnosis of actinic keratosis and detected 16 of 22 (73%) histopathologically confirmed subclinical lesions from perilesional skin sites. By optical coherence tomography assessment, the clearance rate for clinically observed lesions was 76 percent for ingenol mebutate-treated areas versus 11 percent for untreated areas; the clearance rate for treated subclinical lesions was 88 percent versus 43 percent for untreated areas. Clearance rates did not vary with the severity of the local response. CONCLUSION: Optical coherence tomography is effective at detecting clinical and subclinical actinic keratoses and monitoring their response to treatment.

Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study.

Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient's quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient's well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 (P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction.

Differentiation of Basal Cell Carcinoma Subtypes in Multi-Beam Swept Source Optical Coherence Tomography (MSS-OCT).

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.

Evaluation of Optical Coherence Tomography as a Means of Identifying Earlier Stage Basal Cell Carcinomas while Reducing the Use of Diagnostic Biopsy.

OBJECTIVE: To determine the diagnostic accuracy of optical coherence tomography for basal cell carcinoma and the proportion of biopsies that could be avoided if optical coherence tomography is used to rule-in surgery. DESIGN: Multicenter, prospective, observational study. SETTING: Dermatology clinics. PARTICIPANTS: Consecutive patients with clinically challenging pink lesions suspicious for basal cell carcinoma. MEASUREMENTS: Clinical, dermoscopic, and optical coherence tomography images were obtained for all subjects. At each stage, the clinician made a diagnosis (pathology + subtype if applicable), and assessed his/her own confidence in the diagnosis. RESULTS: Optical coherence tomography significantly (p<0.01) improved sensitivity and specificity over clinical or dermoscopic evaluation. The percentage of correct diagnoses was 57.4 percent (clinical), 69.6 percent (dermoscopy), and 87.8 percent (optical coherence tomography). Optical coherence tomography significantly increased the certainty of diagnosis; clinicians indicated they were certain (>95% confident) in 17 percent of lesions examined clinically, in 38.6 percent examined with dermoscopy, and in 70 percent examined with optical coherence tomography. With the use of optical coherence tomography in the diagnosis of basal cell carcinoma, more than 1 in 3 patients could avoid a diagnostic biopsy. CONCLUSION: In a population of clinically challenging lesions, optical coherence tomography improved diagnostic certainty by a factor of four over clinical examination alone and improved diagnostic accuracy by 50 percent (57-88%). The addition of optical coherence tomography to other standard assessments can improve the false-positive rate and give a high degree of certainty for ruling in a positive diagnosis for basal cell carcinoma. A reduction of 36 percent in overall biopsies could be achieved by sending high certainty basal cell carcinoma positive optical coherence tomography diagnoses straight to surgery.