FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3036624594> ?p ?o ?g. }

• W3036624594 abstract "Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB.Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50 cm2 in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline.In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated.SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months.ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015." @default.
• W3036624594 created "2020-06-25" @default.
• W3036624594 creator A5000758369 @default.
• W3036624594 creator A5005883671 @default.
• W3036624594 creator A5020095047 @default.
• W3036624594 creator A5032745734 @default.
• W3036624594 creator A5046034725 @default.
• W3036624594 creator A5048820368 @default.
• W3036624594 creator A5064465434 @default.
• W3036624594 creator A5070662508 @default.
• W3036624594 creator A5078546492 @default.
• W3036624594 creator A5081664185 @default.
• W3036624594 date "2020-06-23" @default.
• W3036624594 modified "2023-10-16" @default.
• W3036624594 title "Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)" @default.
• W3036624594 cites W1850254945 @default.
• W3036624594 cites W1863983288 @default.
• W3036624594 cites W1972578535 @default.
• W3036624594 cites W1975332287 @default.
• W3036624594 cites W1997482425 @default.
• W3036624594 cites W2004212719 @default.
• W3036624594 cites W2010098840 @default.
• W3036624594 cites W2013575934 @default.
• W3036624594 cites W2014299676 @default.
• W3036624594 cites W2034062256 @default.
• W3036624594 cites W2044606526 @default.
• W3036624594 cites W2051788045 @default.
• W3036624594 cites W2074236273 @default.
• W3036624594 cites W2079206263 @default.
• W3036624594 cites W2086743485 @default.
• W3036624594 cites W2101625753 @default.
• W3036624594 cites W2111223638 @default.
• W3036624594 cites W2121137428 @default.
• W3036624594 cites W2140272100 @default.
• W3036624594 cites W2149687254 @default.
• W3036624594 cites W2152991245 @default.
• W3036624594 cites W2158602154 @default.
• W3036624594 cites W2161653724 @default.
• W3036624594 cites W2287953832 @default.
• W3036624594 cites W2310642031 @default.
• W3036624594 cites W2336443089 @default.
• W3036624594 cites W2478595009 @default.
• W3036624594 cites W2560012607 @default.
• W3036624594 cites W2742326456 @default.
• W3036624594 cites W2762496674 @default.
• W3036624594 cites W2783141417 @default.
• W3036624594 cites W3005172635 @default.
• W3036624594 cites W4322695662 @default.
• W3036624594 doi "https://doi.org/10.1186/s13023-020-01419-3" @default.
• W3036624594 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7310548" @default.
• W3036624594 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32576219" @default.
• W3036624594 hasPublicationYear "2020" @default.
• W3036624594 type Work @default.
• W3036624594 sameAs 3036624594 @default.
• W3036624594 citedByCount "6" @default.
• W3036624594 countsByYear W30366245942020 @default.
• W3036624594 countsByYear W30366245942021 @default.
• W3036624594 countsByYear W30366245942022 @default.
• W3036624594 countsByYear W30366245942023 @default.
• W3036624594 crossrefType "journal-article" @default.
• W3036624594 hasAuthorship W3036624594A5000758369 @default.
• W3036624594 hasAuthorship W3036624594A5005883671 @default.
• W3036624594 hasAuthorship W3036624594A5020095047 @default.
• W3036624594 hasAuthorship W3036624594A5032745734 @default.
• W3036624594 hasAuthorship W3036624594A5046034725 @default.
• W3036624594 hasAuthorship W3036624594A5048820368 @default.
• W3036624594 hasAuthorship W3036624594A5064465434 @default.
• W3036624594 hasAuthorship W3036624594A5070662508 @default.
• W3036624594 hasAuthorship W3036624594A5078546492 @default.
• W3036624594 hasAuthorship W3036624594A5081664185 @default.
• W3036624594 hasBestOaLocation W30366245941 @default.
• W3036624594 hasConcept C126322002 @default.
• W3036624594 hasConcept C141071460 @default.
• W3036624594 hasConcept C16005928 @default.
• W3036624594 hasConcept C168563851 @default.
• W3036624594 hasConcept C185592680 @default.
• W3036624594 hasConcept C197934379 @default.
• W3036624594 hasConcept C207103383 @default.
• W3036624594 hasConcept C2776073210 @default.
• W3036624594 hasConcept C2777501473 @default.
• W3036624594 hasConcept C2778375690 @default.
• W3036624594 hasConcept C2778405274 @default.
• W3036624594 hasConcept C2781207856 @default.
• W3036624594 hasConcept C43617362 @default.
• W3036624594 hasConcept C44249647 @default.
• W3036624594 hasConcept C71924100 @default.
• W3036624594 hasConceptScore W3036624594C126322002 @default.
• W3036624594 hasConceptScore W3036624594C141071460 @default.
• W3036624594 hasConceptScore W3036624594C16005928 @default.
• W3036624594 hasConceptScore W3036624594C168563851 @default.
• W3036624594 hasConceptScore W3036624594C185592680 @default.
• W3036624594 hasConceptScore W3036624594C197934379 @default.
• W3036624594 hasConceptScore W3036624594C207103383 @default.
• W3036624594 hasConceptScore W3036624594C2776073210 @default.
• W3036624594 hasConceptScore W3036624594C2777501473 @default.
• W3036624594 hasConceptScore W3036624594C2778375690 @default.
• W3036624594 hasConceptScore W3036624594C2778405274 @default.
• W3036624594 hasConceptScore W3036624594C2781207856 @default.
• W3036624594 hasConceptScore W3036624594C43617362 @default.
• W3036624594 hasConceptScore W3036624594C44249647 @default.

• next