Acne vulgaris is a common condition in adolescence and also for many women of childbearing age. The management of acne in pregnancy is complicated by the lack of clinical studies and pharmacokinetic data in this patient population and safety concerns regarding retinoid use in pregnancy. Of primary concern to both patients and clinicians is the safety profile of medications used during pregnancy. This review seeks to clarify what management options are available to treat acne during pregnancy and what data are available to guide decision making. Topical treatments are considered the safest option during pregnancy. They have the best safety profile and minimize the levels of systemic absorption, and therefore the least risk of fetal exposure. If these are applied properly with a strong emphasis on adherence, excellent results can be achieved.
Background Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4–8% develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up. Methods We aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation. Discussion If the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma. Trial registration Clinical Trials.gov, NCT03328247 . Registered on 1 November 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3453-x) contains supplementary material, which is available to authorized users.
Background: Melanoma is common, 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased five-fold in 30 years. Melanoma affects old and young people with poor prognosis once metastatic. UK guidelines recommends people treated for cutaneous melanoma receive extended outpatient hospital follow-up to detect recurrence or new primaries. Such follow-up to the growing population of melanoma survivors is burdensome for both individuals and health services. Follow-up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4-8% develop a new primary, the risk of both is highest in the first five years. ASICA (Achieving Self-directed Integrated Cancer Aftercare) is a digital intervention to increase Total-Skin-Self-Examination (TSSE) by people treated for melanoma, with usual follow-up. Methods: We aim to recruit 240 adults with a previous first stage 0-2C primary cutaneous melanoma from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL EQ-5D-5L, and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomisation along with a 12 month review of clinical data. 12 months following randomisation will be considered the primary timepoint for outcome analyses. Discussion: If the ASICA intervention improves total-skin-self-examination practice in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and NHS resources. This study will determine if a full scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed determine the effectiveness ASICA is a pilot study evaluating the effectiveness of total skin self-examination practice in those affected by melanoma. Trial Registration: Clinical Trials.gov :Trial registration number NCT03328247. Registered 01 November 2017, https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1. First participant randomised on 25 January 2018. Keywords: Primary care, Melanoma, Cancer, Randomised Controlled Trial, Survivorship, Self-directed care, e-health, ASICA.
Malignant melanoma is an aggressive form of cancer, which can be treated with anti-CTLA-4 and anti-PD-1 checkpoint inhibitor antibodies but while anti-CTLA-4 antibodies have clear benefits for some patients with melanoma, productive responses are difficult to predict and often associated with serious immune related adverse events. Antibodies specific to CTLA-4 bind two major isoforms of CTLA-4 in humans, the receptor isoform and a second naturally secretable, soluble isoform - sCTLA-4. The primary aim here was to examine the effect of selectively blocking the function of sCTLA-4 on in vitro immune responses from volunteer healthy or melanoma patient PBMC samples. Addition of recombinant sCTLA-4 to healthy PBMC samples demonstrated sCTLA-4 to have immunosuppressive capacity comparable to recombinant CTLA4-Ig, partially reversible upon antibody blockade. Further, we identified a mechanistic relationship where melanoma patient TGFβ2 serum levels correlated with sCTLA-4 levels and provided the basis for a novel protocol to enhance sCTLA-4 production and secretion by T cells with TGFβ2. Finally, a comparison of selective antibody blockade of sCTLA-4 demonstrated that both healthy and melanoma patient effector cytokine responses can be significantly increased. Overall, the data support the notion that sCTLA-4 is a contributory factor in cancer immune evasion.
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