[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645761":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":44,"studyPopulation":31,"armGroups":45,"interventions":58,"overallOfficials":31,"centralContacts":69,"locations":75,"responsibleParty":95,"collaborators":31,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":31,"eligibilityCriteria":102,"healthyVolunteers":99,"sex":103,"minAge":104,"maxAge":31,"enrollmentInfo":105,"targetDuration":31,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":78,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"KTH Biopharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"The efficacy","Number of patients with complete elimination of all genital warts lesions during the 12-week treatment period. Patients who achieved complete elimination of genital warts during treatment were assessed for recurrence within 4-6 months after the last treatment. The lession area is measured in cm2 or mm2.","1-12 weeks of treatment",{"measure":14,"description":15,"timeFrame":12},"The Safety","Percentage of patients experiencing at least one adverse event, percentage of patients experiencing at least one serious adverse event, the number of adverse events in each group.",[17,20,24,28],{"measure":18,"description":19,"timeFrame":12},"Partial elimination","Number of patients with partial elimination, defined by a reduction of \\>50% in lesion area compared to pre-treatment lesions at week 0 or week 6 (if recurrence). Lession area is measured in cm2.",{"measure":21,"description":22,"timeFrame":23},"New lesions","Number of patients with new lesions: assessment and comparison of the number, morphology, location, size (in cm or mm), and area (in cm2 or mm2) of recurrent lesions at weeks 3, 6, 9, and 12 (visually and with topical acetic acid).","1 week-6 months",{"measure":25,"description":26,"timeFrame":27},"Recurrence rate","Number of patients with recurrence rate: The recurrence rate is defined as the percentage of patients who were completely cured during treatment and experienced recurrent genital warts during the follow-up period.","4-6 months after the last treatment",{"measure":29,"description":30,"timeFrame":27},"HPV clearance criteria","Number of patients with HPV clearance criteria: comparison of the percentage of positive HPV PCR at week 36 (after the last treatment) in patients who were completely cured during treatment.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"QUADRUPLE","A randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo.",[40,41,42,43],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Phase II, randomized, controlled and double blind clinical trial to evaluate the effectiveness and recurrence of genital warts by CO2 laser combined with Geniwa gel treatment compared Sixty to eighty patients with a history of genital warts that were resistant to conventional treatments were enrolled in a randomized, double-blind, placebo-controlled study comparing a combination of CO2 laser and Geniwa gel and a combination of CO2 laser and placebo gel.\n\nIn the first phase of the study, 60-80 patients were randomly assigned to 2 groups. The first group received a combination of CO2 laser and Geniwa gel for 6 weeks. The second group received a combination of CO2 laser and placebo gel for 6 weeks.\n\nOn day 1, after CO2 laser treatment, Geniwa gel (5% alpha lactalbumin-oleic acid) or saline placebo gel was applied to each lession by investigator. The lession was coverd with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours (during the night). Thereafter, the patients followed the same procedure at home once a day and received a new coded bottle (Geniwa or placebo gel) weekly in the clinic. The genital warts lession were inspected, measured, and photographed at enrollment, at week 2- 12 during treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured, with use of a slide caliper, and the volume of each genital warts was calculated.\n\nIf genital warts recur during the first six-week period, CO2 laser treatment will be applied, followed by the continued use of a placebo or Geniwa topical gel.\n\nThe randomization code was broken after all patients had completed six weeks of the randomly assigned treatment.\n\nGeniwa gel is predicted superior to placebo. For this reason, patients in both groups were offered six weeks of open-label treatment with Geniwa gel according to the protocol used in the first, randomized phase of the study.\n\nThe patients participating in the second phase did not know whether they had received Geniwa or placebo during the first treatment period. After the end of open-label treatment with Geniwa, the patients were allowed to use conventional treatment if they wished it.\n\nA short-term follow-up investigation was performed approximately 4-6 months after the completion of the second (open-label) treatment period. The sites of treated lesions and possible new lesions were inspected, and the patients were interviewed about the length of time to the resolution of their lesions, about potential other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.\n\nFor patients who experience bleeding or significant wound pain after CO2 laser treatment, Geniwa or placebo topical gel application may not be possible until 1-2 days later.\n\nAdditionally, patients who undergo CO2 laser treatment are prescribed oral cefotaxime (for 7 days) and topical Tyrosur gel (Tyrothricin) daily (1-3 days) in the morning to reduce infection and promote wound healing. Tyrosur gel is used at different times of the day than placebo\u002FGeniwa gel.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Combination of CO2 laser and placebo gel","PLACEBO_COMPARATOR","Placebo gel contains saline gel",[51],"Other: Placebo gel",{"label":53,"type":54,"description":55,"interventionNames":56},"Combination of CO2 laser and Geniwa gel","EXPERIMENTAL","Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes",[57],"Drug: Geniwa gel",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":31},"DRUG","Geniwa gel","Geniwa gel contains alpha lactalbumin-oleic acid 5%",[53],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":31},"OTHER","Placebo gel","Placebo gel contains saline",[47],[70],{"name":71,"role":72,"phone":73,"phoneExt":31,"email":74},"Thanh Tam Tran, MD","CONTACT","+84383744842","Tranthanhtam.fmh@gmail.com",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"National Dermatology Hospital, Hanoi, Vietnam.","RECRUITING","Hanoi","None (International)","121000","Vietnam","VN",{"type":85,"coordinates":86},"Point",[87,88],105.84117,21.0245,{"lat":88,"lon":87},[91],{"name":92,"role":72,"phone":93,"phoneExt":31,"email":94},"Huy Luong Vu, MD, PhD","+84918150368","huyluong84@gmail.com",{"type":96,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100645761","phase-2-treatment-of-recurrent-genital-warts-by-combination-of-co2-laser-and-geniwa-gel-100645761",false,"NCT07698886","Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Able to read and understand the Patient Information Sheet and the Informed Consent form.\n3. Acceptance in the participation of the essay and signature of the Informed Consent form.\n4. Diagnosis of genital and anal warts with clear clinical manifestations.\n5. Have undergone at least 2 laser treatments and have experienced recurrence in any location.\n6. At least four or more lesions, or a lesion area of at least 0.5 cm2.\n\nExclusion Criteria:\n\n1. Concomitant sexually transmitted infections such as gonorrhea, syphilis, genital herpes, etc., that have not been cured.\n2. Ulceration or suspected malignant transformation of the lesions.\n3. Local infections.\n4. Pregnant women.\n5. Allergies to any component of alpha-lactalbumin-oleic acid gel.","ALL","18 Years",{"count":106,"type":107},70,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","Phase II, a randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo. The clinical trial is conducted at National Dermatology Hospital, Hanoi, Vietnam.",[113,114],"HPV (Human Papillomavirus)-Associated","Genital Warts",[116,117],"HPV","Genital warts","2026-08-19",{"date":120,"type":121},"2026-08-21","ACTUAL",{"date":123,"type":121},"2026-07-16",{"date":125,"type":107},"2027-09-15",{"name":5,"class":6},1]