Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever occurs later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.
Skin, mental health and the central nervous system (CNS) are connected by a deep link. It is not only the aesthetic and sometimes the disfiguring aspects of dermatological conditions that can cause a severe psychological burden; also, different studies have shown how chronic skin-inflammatory diseases may influence the activity of the CNS and vice versa. Moreover, the skin and brain share a common embryogenic origin. Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease affecting the hair follicles of the apocrine regions. The main clinical features are nodules, abscesses, cysts, fistulae and disfiguring scars. Pain and stinking discharge from fistulae are often present. It is not surprising that the psychological burden associated with HS is frequently a challenge in dermatologists’ daily routines. Patients often suffer from depression and anxiety, but also from substance abuse, psychotic and bipolar disorders and an increased suicide risk. The aim of this article is to review the main psychiatric disorders associated with HS and their pathophysiology. Research on Pubmed was conducted with the key words Hidradenitis suppurativa, psychiatric, depression, anxiety, bipolar, schizophrenia, abuse, suicidal. A high incidence of psychiatric disorders has been described in HS compared to controls. Hidradenitis suppurativa is not a rare disease, and acknowledging the HS psychological burden, psychiatric-associated diseases and associated biomolecular pathways will help dermatologists to better care for their patients.
Topical photodynamic therapy (PDT) is a non-invasive treatment modality frequently used in dermatology to treat superficial skin cancers but also some inflammatory or infectious dermatoses. PDT appears a more and more promising therapeutic option also for cutaneous lymphomas, either of T- or B-cell origin. It is a well-tolerated treatment and has excellent cosmetic outcomes, less side effects compared to other therapies (steroids, surgery, radiotherapy, and so on), no particular contraindications, and is easily repeatable in case of relapses. However, how PDT works in the treatment of cutaneous lymphoproliferative diseases is poorly understood and the literature data are still controversial. Further randomized, controlled clinical trials involving a greater number of patients and centers with a long follow-up are necessary to assess the efficacy of PDT and establish a unique standardized treatment protocol in relation to the lymphomatous disease and the type, thickness, and location of the lesions.
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