[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598524":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":52,"centralContacts":65,"locations":71,"responsibleParty":89,"collaborators":52,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":52,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":52,"overallStatus":74,"whyStopped":52,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Noxopharm Limited","INDUSTRY",[8,15,20,25,30,34,38,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","ACTIVE_COMPARATOR","Single application of 2 g SOF-SKN cream 2.5 mg\u002Fg (0.25% w\u002Fw) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[13,14],"Drug: SOF-SKN 0.25%","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2","Single application of 2 g SOF-SKN cream 5 mg\u002Fg (0.5% w\u002Fw) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[19,14],"Drug: SOF-SKN 0.5%",{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 3","Single application of 2 g SOF-SKN cream 10 mg\u002Fg (1% w\u002Fw) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[24,14],"Drug: SOF-SKN 1%",{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 4","Single application of 2 g SOF-SKN cream 20 mg\u002Fg (2% w\u002Fw) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[29,14],"Drug: SOF-SKN 2%",{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 5","Multiple applications of 2 g SOF-SKN cream 2.5 mg\u002Fg (0.25% w\u002Fw) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[13,14],{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort 6","Multiple applications of 2 g SOF-SKN cream 5 mg\u002Fg (0.5% w\u002Fw) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[19,14],{"label":39,"type":10,"description":40,"interventionNames":41},"Cohort 7","Multiple applications of 2 g SOF-SKN cream 10 mg\u002Fg (1% w\u002Fw) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[24,14],{"label":43,"type":10,"description":44,"interventionNames":45},"Cohort 8","Multiple applications of 2 g SOF-SKN cream 20 mg\u002Fg (2% w\u002Fw) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.",[29,14],[47,53,56,59,62],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","SOF-SKN 0.25%","cream for topical application",[9,31],null,{"type":48,"name":54,"description":50,"armGroupLabels":55,"otherNames":52},"SOF-SKN 0.5%",[16,35],{"type":48,"name":57,"description":50,"armGroupLabels":58,"otherNames":52},"SOF-SKN 1%",[21,39],{"type":48,"name":60,"description":50,"armGroupLabels":61,"otherNames":52},"SOF-SKN 2%",[26,43],{"type":48,"name":63,"description":50,"armGroupLabels":64,"otherNames":52},"Placebo",[9,16,21,26,31,35,39,43],[66],{"name":67,"role":68,"phone":69,"phoneExt":52,"email":70},"Gisela Mautner, MD-PhD","CONTACT","+ 61 2 9144 2223","medical.information@noxopharm.com",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":52,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Doherty Clinical Trials","RECRUITING","Melbourne","Victoria","Australia","AU",{"type":80,"coordinates":81},"Point",[82,83],144.96332,-37.814,{"lat":83,"lon":82},[86],{"name":73,"role":68,"phone":87,"phoneExt":52,"email":88},"+61(03) 9970 4200","info@dohertyclinicaltrials.com",{"type":90,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100598524","early-phase-1-clinical-trial-to-evaluate-safety-tolerability-and-pharmacokinetics-of-sof-skn-in-healthy-participants-100598524",false,"NCT07072611","Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants","A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants","HERACLES","Inclusion Criteria:\n\n* Healthy Volunteers 18 to 64 years.\n* Participants with Fitzpatrick skin type I to IV.\n* Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.\n* No Allergies.\n* Contraception.\n* Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.\n\nExclusion Criteria:\n\n* Allergic constitution.\n* Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.\n* Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.\n* Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.\n* Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and\u002For suntan\u002Fburn that could interfere with the test field evaluation.\n* Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and\u002For scabs) present in the target area on the back that could interfere with the test field evaluation.\n* Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.\n* Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.",true,"ALL","18 Years","64 Years",{"count":104,"type":105},32,"ESTIMATED","INTERVENTIONAL",[108],"EARLY_PHASE1","The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.\n\nPart 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.",[111],"Cutaneous Lupus Erythematosus","2025-07-17",{"date":114,"type":115},"2025-07-20","ACTUAL",{"date":117,"type":115},"2025-07-14",{"date":119,"type":105},"2026-03",{"name":5,"class":6},1]