A multi-centre, open, investigator initiated phase IV clinical trial to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% on the face and scalp, and 0.05% on the trunk and extremities, in Korean patients with actinic keratosis (PERFECT)

Abstract

Background

Ingenol mebutate gel is a novel, field-directed topical treatment for actinic keratosis (AK). Most pivotal studies have targeted Western populations. No clinical study has been conducted to investigate its efficacy and safety in Asian populations.

Objectives

To evaluate the efficacy and safety of ingenol mebutate gel for treating AK of face/scalp and trunk/extremities in a large Asian (Korean) population.

Methods

In this multi-centre, open-label, interventional, parallel group, prospective phase 4 study (PERFECT, NCT02716714), the eligible subjects were allocated into either the face/scalp or the trunk/extremities group, according to their selected treatment area location. After application of ingenol mebutate gel, the subjects were followed-up for 6 months. The primary efficacy endpoint was complete clearance (CC) rate of AK lesions in the selected treatment area on Day 57. The quality of life was evaluated using Skindex-29. Safety endpoints included local skin responses, scar, pigmentation, pain, and adverse events.

Results

In total, 78.1% (95% CI: 66.86–86.92%) of subjects had CC on day 57, with 76.6% (95% CI: 64.31–86.25%) in face/scalp group and 88.9% (95% CI: 51.75–99.72%) in trunk/extremities group. Among them, the CC rate was sustained in 88.9% (48/54 subjects, 95% CI: 77.37–95.81%) on Month 6. The local skin responses significantly increased 1 day after the treatment compared to baseline, and decreased afterwards. Among the total subjects, 7.8% (6/77 subjects) had hyperpigmentation on the application area. Scars were not reported.

Conclusions

Ingenol mebutate is effective for the treatment of AK in Asians, with tolerable safety profiles.

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Severe cutaneous adverse reactions due to inappropriate medication use

Summary

Backgroud

The proportion of severe cutaneous adverse reactions (SCARs) that could be avoided if medication use was consistent with good medical practice is unknown.

Objectives

To estimate the proportion of SCARs related to inappropriate medication use.

Methods

Retrospective study of all validated SCARs collected in a French registry between 2003 and 2016. For each case, all plausible drugs suspected to induce SCARs (i.e., not just the drug regarded as "the most probable") were considered regarding three causes of preventability: (1) prescription for an inappropriate indication, (2) unintentional rechallenge despite a previous allergy to the drug, or (3) self-medication with prescription medicines.

Results

602 cases were included in the analyses. Antibiotics, anticonvulsants and allopurinol were the drugs most frequently involved, accounting for more than 50% of all cases. All suspected medications were considered appropriately used for 417 of the 602 individuals included in the study population (69.3%, 95% CI [65.6-73.0]),and inappropriately used. for 144 individuals (23.9% [20.5-27.3]).. These inappropriate uses were mainly due to prescriptions for inappropriate indication (65.8% [58.4-73.2]) or unintentional rechallenge (20.9% [14.6-27.2]). Allopurinol and cotrimoxazole were the drugs most frequently involved in inappropriate indications (accounting for 51.9% [42.3-61.5] and 13.5% [6.9-20.1] of cases, respectively). Antibiotics were the largest group involved in unintentional rechallenge. Non-steroidal anti-inflammatory drugs available on prescription were most involved in inappropriate self-medication.

Conclusions

Our results underline the need for respecting the appropriate indication of drugs to reduce the incidence of SCARs. All efforts to reduce unintentional rechallenge also seem to be necessary preventive measures.

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Aprepitant did not modify global disease activity in cutaneous T cell lymphomas

Abstract

Recent investigations are focused on the potential antitumor effect of neurokinin-1 receptor (NK1R) antagonists in different neoplastic diseases¹. Consequently, Kwatra et al. raised an interesting observation about the possible influence of aprepitant on CTCL outcome².

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Effects of neuroimmune axis modulation by aprepitant on anti-pruritic and global disease severity in patients with cutaneous T-cell lymphoma

Abstract

Itch pathogenesis involves modulation of the neuroimmune axis, with several immunosuppressants such as azathioprine¹ and mycophenolate mofetil² demonstrating significant anti-pruritic activity in subsets of patients with pruritus. These immunosuppressive agents are contraindicated in patients with malignancy, and thus there is a need for novel anti-pruritic agents without significant immunosuppressive effects in neoplastic conditions such as cutaneous T cell lymphoma (CTCL).

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From Foundation to Demolition: The Influence of Perioperative Tranexamic Acid

No abstract available

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The Impact of Prehospital Tranexamic Acid on Blood Coagulation in Trauma Patients

BACKGROUND: There is limited data on prehospital administration of tranexamic acid (TXA) in civilian trauma. The aim of this study was to evaluate changes in coagulation after severe trauma from on-scene to the hospital after TXA application in comparison to a previous study without TXA. METHODS: The study protocol was registered at ClinicalTrials.gov (NCT02354885). A prospective, multicenter, observational study investigating coagulation status in 70 trauma patients receiving TXA (1 g intravenously) on-scene versus a control group of 38 patients previously published without TXA. To account for potential differences in patient and trauma epidemiology, crystalloid and colloidal resuscitation fluid, 2 propensity score matched groups (n = 24 per group) were created. Measurements included ROTEM, standard coagulation tests and blood gas analyses on-scene and emergency department admission. Presented values are mean and [standard deviation], and difference in means and 95% confidence intervals. RESULTS: Patient epidemiology was not different between groups. Coagulation assays on-scene were comparable between the TXA and C. Prehospital hyperfibrinolysis was blunted in all 4 patients in the TXA group. Viscoelastic FIBTEM maximum clot firmness (MCF), representing functional fibrinogen levels, did not change from on-scene to the emergency department in the TXA group, whereas MCF decreased −3.7 [1.8] mm in the control group. Decrease of MCF was significantly reduced in the TXA group in EXTEM by 9.2 (7.2–11.2) mm (P

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A Tale of Two Solutions: High vs Low-Chloride Intravenous Fluids

No abstract available

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