Drugs / Silver Sulfadiazine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) SILVADENE 1973-11-26 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT03574935 Jul 2018 → Sep 2019 ulcer disease Shanghai Yueyang Integrated Medicine Hospital Unknown No outcome recorded
Phase 2 NCT00332163 Apr 2006 → Jan 2008 colorectal cancer, exanthem, toxic dermatosis Amgen Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01553708 Dec 2011 → May 2012 Chulalongkorn University Completed No outcome recorded
Phase 31 trial
Phase 3 NCT01017094 Sep 2007 → Jun 2008 bone disorder Prince of Songkla University Completed No outcome recorded
Phase 42 trials
Phase 4 NCT01926392 Apr → Oct 2011 University of Virginia Completed No outcome recorded
Phase 4 NCT00156988 Mar 2004 → Dec 2005 Association of Dutch Burn Centres Completed No outcome recorded
Phase not applicable1 trial
NCT04277182 Sep 2020 Izmir Katip Celebi University Completed No outcome recorded
Also used as a comparator or background therapy in 22 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02116010 Comparator Jul 2015 → Jul 2016 skin infection Phagenix Unknown No outcome recorded
Phase 24 trials
Phase 2 NCT01297400 Comparator Mar 2022 → Dec 2026 expected Skingenix, Inc. Recruiting No outcome recorded
Phase 2 NCT03162367 Comparator Apr 2019 → Mar 2020 SCARM Institute, Tabriz, Iran Completed No outcome recorded
Phase 2 NCT04391582 Comparator May 2017 → Apr 2018 Drug Research and Development Center, Federal University of Ceara Completed No outcome recorded
Phase 2 NCT03592498 Comparator Oct 2016 → Sep 2017 Drug Research and Development Center, Federal University of Ceara Completed No outcome recorded
Phase 33 trials
Phase 3 NCT03791710 Comparator Mar 2019 → Jan 2020 Ahmed Mohamed Abouzaid Completed No outcome recorded
Phase 3 NCT04202289 Comparator Apr 2017 → Oct 2018 Drug Research and Development Center, Federal University of Ceara Completed No outcome recorded
Phase 3 NCT02109718 Comparator Jan 2009 → Jul 2010 University of the Philippines Completed No outcome recorded
Phase 45 trials
Phase 4 NCT06872151 Comparator Mar 2025 anus disorder, hemorrhoid University of Cagliari Completed No outcome recorded
Phase 4 NCT04601532 Comparator Jun 2021 → Dec 2022 J. Peter Rubin, MD Terminated No outcome recorded
Phase 4 NCT02108535 Comparator Nov 2013 → Aug 2014 University of Sorocaba Completed No outcome recorded
Phase 4 NCT00634166 Background Sep 2007 → Dec 2013 Mylan Inc. Terminated No outcome recorded
Phase 4 NCT00297752 Comparator Mar 2006 → Dec 2008 Association of Dutch Burn Centres Completed No outcome recorded
Phase not applicable8 trials
NCT07367087 Comparator Feb → Aug 2026 overdue Nishtar Medical University Not yet recruiting No outcome recorded
NCT05073172 Comparator Jan → Dec 2024 breast carcinoma, head and neck carcinoma, radiodermatitis OHSU Knight Cancer Institute Withdrawn No outcome recorded
NCT05877638 Comparator Mar 2023 → Jun 2024 Synedgen, Inc. Terminated No outcome recorded
NCT02497326 Comparator Apr → Dec 2015 King Edward Medical University Unknown No outcome recorded
NCT01598480 Comparator May 2012 → Mar 2014 Bio-medical Carbon Technology Co., Ltd. Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as silversulfadiazine “'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin;...” NCT00634166
24

“This multicenter, randomized, controlled trial thus investigates the effectiveness of cerium nitrate-silver sulfadiazine in the treatment of facial burns compared with silver...” PMID 22842424 Aug 2012

“Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.” NCT03592498

“1% Silver Sulfadiazine will be applied topically to rats for 21 days.” NCT04277182

“topical medical treatment (eg, silver sulfadiazine, Silvadene)” NCT00332163

silversulfadiazine (flammazine)” NCT00297752

“Silver sulfadiazine cream” NCT01598493

“Silver Sulfadiazine” NCT02099240

NCT06872151

NCT00156988

NCT02116010

NCT01553708

NCT01297400

NCT00641433

NCT04202289

NCT04601532

NCT02109718

NCT03162367

NCT02108535

NCT01926392

NCT07367087

NCT05073172

NCT05877638

NCT01017094

NCT04391582

Known as Flamazine ClinicalTrials.gov intervention name — accepted as the source's own label NCT01598480
Known as flammazine “silversulfadiazine (flammazine)” NCT00297752
Known as Silvadene SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and...” NCT05877638
1

Silvadene® Cream 1% [Silver Sulfadiazine]” NCT01297400

Known as Silvadene Topical Product Silvadene Topical ProductNCT04601532
Known as silver sulphadiazine “Polyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash” NCT02497326
2

“serial dressing with topical agents e.g Silver SulphadiazineNCT03791710

NCT01439074

Known as SSD “silver sulfadiazine (SSD) 1% cream” NCT01439074
Known as Sulfadiazine Silver “2.1% Sulfadiazine Silver Cream(lesions with infection)” NCT03574935
Modality Small molecule “Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.” NCT04601532
Route Topical topical silver sulfadiazine cream” NCT00641433