Nctid:
NCT06228521
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014860", "term"=>"Warts"}], "ancestors"=>[{"id"=>"D030361", "term"=>"Papillomavirus Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D017193", "term"=>"Skin Diseases, Viral"}, {"id"=>"D014412", "term"=>"Tumor Virus Infections"}, {"id"=>"D012874", "term"=>"Skin Diseases, Infectious"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M17603", "name"=>"Warts", "asFound"=>"Warts", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M23687", "name"=>"Papillomavirus Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19501", "name"=>"Skin Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M17162", "name"=>"Tumor Virus Infections", "relevance"=>"LOW"}, {"id"=>"M15677", "name"=>"Skin Diseases, Infectious", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>44}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-03-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-04-22", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Skin pattern", "timeFrame"=>"7 days from first application", "description"=>"Interrupted plantar lines with irregularly distributed dots.classifies the severity in 3 degrees, from the absence of alterations (0) to the extensive presence of interrupted lines and irregular spots in the plantar skin pattern (3)."}], "secondaryOutcomes"=>[{"measure"=>"VAS scale", "timeFrame"=>"7 days from first application", "description"=>"It is a tool to allow the patient to evaluate the intensity of the pain on a visual scale of 0-10, where 0 is nothing and 10 is unbearable, being a subjective evaluation."}, {"measure"=>"complications", "timeFrame"=>"7 days from first application", "description"=>"complications including the possibility of recurrence, discomfort or pain during or after treatment, risk of infection at the treated site, potential for scarring or changes in skin appearance, hypersensitivity or allergies to the drugs used, changes in skin pigmentation, and in rare cases, possibility of damage to surrounding structures such as nerves or blood vessels."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["cryotherapy", "laser therapy", "papillomaviridae", "plantar warts", "randomised clinical trial"], "conditions"=>["Warts of Foot"]}, "referencesModule"=>{"references"=>[{"pmid"=>"33031838", "type"=>"RESULT", "citation"=>"Liu JJ, Li HT, Ren YY, Yang F, Cheng ZH, Xia TB, Liu JL, Cao XJ, Lu SC. Long-pulsed neodymium-doped yttrium-aluminum-garnet laser versus cryotherapy for the treatment of cutaneous warts: A randomized controlled trial. J Am Acad Dermatol. 2022 Dec;87(6):1328-1335. doi: 10.1016/j.jaad.2020.09.085. Epub 2020 Oct 5."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to compare and test the efficacy of two treatments for plantar warts. The main questions it aims to answer are:\n\nWhich treatment has a higher cure rate for eliminating plantar warts? Which treatment causes less pain during the procedure?\n\nParticipants with plantar warts will:\n\nBe randomly assigned to receive either cryotherapy or laser therapy Undergo 4 treatment sessions at weekly intervals Have their warts assessed for complete clearance after treatment Rate their pain levels during each session\n\nResearchers will compare the cryotherapy and laser therapy groups to see if there are differences in:\n\nRates of complete wart clearance Pain levels reported during treatment Adverse effects", "detailedDescription"=>"Background: Plantar warts are a common dermatological condition caused by human papillomavirus infection. They can be painful and negatively impact quality of life. Many treatments exist but there is lack of consensus on the optimal approach.\n\nObjectives:\n\nPrimary objective: To compare the efficacy of 980nm diode laser versus liquid nitrogen cryotherapy for clearing plantar warts, as measured by the complete clearance rate at 4 weeks post-treatment.\n\nSecondary objectives: To evaluate and compare pain levels during treatment procedures and adverse events between both groups.\n\nStudy design: Randomized, double-blind clinical trial.\n\nParticipants: 32 patients aged 18-65 years old with 1-3 plantar warts located on weight-bearing areas of the foot.\n\nInterventions:\n\nLaser group: 980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.\n\nCryotherapy group: Liquid nitrogen sprayed on each wart using a standardised technique. Freeze-thaw cycle repeated up to 3 times per wart per session. 4 sessions at weekly intervals.\n\nMain outcomes:\n\nComplete clearance rate of plantar warts at 4 weeks treatment session. Assessed by physical examination.\n\nPain during procedure measured with Visual Analogue Scale (VAS). Adverse events monitored during follow-up.\n\nRandomization and blinding: Subjects will be randomly allocated to each group with a 1:1 ratio. Investigators assessing outcomes will be blinded to group assignment.\n\nAnalysis: Intention-to-treat analysis will be performed. Chi-squared test will compare clearance rates. T-test will compare pain scores."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with recalcitrant, mosaic and simple HPV\n\nExclusion Criteria:\n\n* Diabetic, ischaemic and immunosuppressed patients\n* Patients with cold intolerance\n* Patients with any of the following conditions (blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenemia, collagen or autoimmune disease)\n* Patients who do not sign the informed consent form."}, "identificationModule"=>{"nctId"=>"NCT06228521", "acronym"=>"LAVsCryWarts", "briefTitle"=>"Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts", "organization"=>{"class"=>"OTHER", "fullName"=>"Fundación Universidad Católica de Valencia San Vicente Mártir"}, "officialTitle"=>"Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of Plantar Warts", "orgStudyIdInfo"=>{"id"=>"UCV/2022-2023/080"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Laser Group", "description"=>"LASEmaR MINI 980 nm", "interventionNames"=>["Other: 980nm diode laser applied"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Cryotherapy group:", "description"=>"CryoIQ", "interventionNames"=>["Other: Liquid nitrogen sprayed"]}], "interventions"=>[{"name"=>"Liquid nitrogen sprayed", "type"=>"OTHER", "description"=>"Liquid nitrogen sprayed on each wart using a standardised technique. Freeze-thaw cycle repeated up to 3 times per wart per session. 4 sessions at weekly intervals.", "armGroupLabels"=>["Cryotherapy group:"]}, {"name"=>"980nm diode laser applied", "type"=>"OTHER", "description"=>"980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.", "armGroupLabels"=>["Laser Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"95128", "city"=>"Catania", "state"=>"Sicilia", "country"=>"Italy", "facility"=>"Studio di Podologia Dr.Secolo", "geoPoint"=>{"lat"=>37.49223, "lon"=>15.07041}}, {"zip"=>"46001", "city"=>"Valencia", "state"=>"València", "country"=>"Spain", "facility"=>"Clinicas UCV", "geoPoint"=>{"lat"=>39.46975, "lon"=>-0.37739}}], "overallOfficials"=>[{"name"=>"Javier Ferrer-Torregrosa, Dr.", "role"=>"STUDY_DIRECTOR", "affiliation"=>"FundaciónUcv"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fundación Universidad Católica de Valencia San Vicente Mártir", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
