[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659198":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":41,"armGroups":46,"interventions":53,"overallOfficials":41,"centralContacts":58,"locations":67,"responsibleParty":84,"collaborators":41,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":41,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":41,"studyType":99,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":114,"whyStopped":41,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"ICIM International S.r.l.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Investigator's Global Assessment (IGA) Score","Clinical improvement will be assessed using the Investigator's Global Assessment (IGA), a 5-point scale ranging from 0 to 4: 0 = absent, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. The IGA provides an overall assessment of the intensity and extent of the clinical manifestations, with particular consideration of scaling and erythema. Change in IGA score from baseline (T0) will be assessed at subsequent study visits. A decrease in the IGA score indicates clinical improvement.","Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)",[14,17,20,24,27,31],{"measure":15,"description":16,"timeFrame":12},"Change From Baseline in Erythema Score","Erythema will be assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of erythema, 1 very mild erythema, 2 mild erythema, 3 moderate erythema, and 4 severe erythema. Higher scores indicate greater severity\u002Fworse outcome. Change from baseline in erythema score will be evaluated at each post-baseline study time point.",{"measure":18,"description":19,"timeFrame":12},"Change From Baseline in Scaling Score","Scaling will be assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of scaling, 1 very mild scaling, 2 mild scaling, 3 moderate scaling, and 4 severe scaling. Higher scores indicate greater severity\u002Fworse outcome. Change from baseline in scaling score will be evaluated at each post-baseline study time point.",{"measure":21,"description":22,"timeFrame":23},"Percentage of Participants With at Least a 1-Point Change From Baseline in Investigator's Global Assessment (IGA) Score Toward Lower Severity","Participants will be classified as meeting the clinical response criterion if they have at least a 1-point change from baseline in the Investigator's Global Assessment (IGA) score toward lower severity at a post-baseline study time point. The IGA is assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of disease signs, 1 very mild, 2 mild, 3 moderate, and 4 severe. Higher scores indicate greater severity\u002Fworse outcome. The percentage of participants meeting this criterion will be calculated at each post-baseline study time point.","Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)",{"measure":25,"description":26,"timeFrame":23},"Investigator's Global Assessment of Clinical Improvement Compared With Baseline","The Clinical Investigator will provide an overall assessment of clinical improvement compared with baseline (T0). At each post-baseline assessment, the participant's overall clinical condition will be classified as improved, unchanged, worsened, or not evaluable compared with baseline.",{"measure":28,"description":29,"timeFrame":30},"Number and Percentage of Participants With Local Cutaneous Reactions","Local cutaneous reactions will be assessed based on events observed by the Clinical Investigator or reported by the participant's parent or legal guardian during the study. Local cutaneous reactions may include erythema, irritation, pruritus, or other skin reactions at the application site. For each reaction, the description, onset date, duration, intensity, location, relationship to the study product, action taken, and outcome will be recorded in the case report form. The number and percentage of participants with at least one local cutaneous reaction will be summarized.","From baseline through the follow-up visit, 28 days after Day 24 (±3 days)",{"measure":32,"description":33,"timeFrame":23},"Caregiver-Reported Responses on the Parent\u002FLegal Guardian Product Evaluation Questionnaire","Caregivers will complete a structured parent\u002Flegal guardian product evaluation questionnaire assessing perceived improvement in the participant's cutaneous manifestations, child comfort\u002Ftolerability, cosmetic acceptability, product use experience, overall satisfaction, and willingness to purchase or recommend the product. The perceived improvement section includes items assessed using a 5-point agreement scale ranging from 1 to 5, where 1 indicates \"not at all agree\" and 5 indicates \"completely agree\"; higher scores indicate a more favorable caregiver-reported perception of improvement. Other questionnaire items use categorical response options and will be summarized descriptively as counts and percentages by response category. No total questionnaire score is planned.",[35],{"measure":36,"description":37,"timeFrame":23},"Number and Percentage of Participants by Clinical Investigator's Overall Wood's Lamp Assessment Category Compared With Baseline","Affected skin areas will be assessed by the Clinical Investigator using a Wood's lamp. The assessment will include clinical observation of fluorescence-related findings, such as presence or absence of fluorescence, qualitative changes in fluorescence color or intensity, fluorescence distribution, and estimated extent of the fluorescent area. These observations will be used to assign one overall categorical Wood's lamp assessment compared with baseline at each post-baseline visit. Categories will be: improved, unchanged, worsened, or not evaluable. The number and percentage of participants in each category will be summarized at each post-baseline study time point.",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE","This is a prospective, interventional, single-center, single-arm clinical study conducted at Meyer Children's Hospital IRCCS in Florence, Italy. The study is expected to enroll 20 pediatric participants aged 0 to 3 years.\n\nNeonatal hyperseborrhea, commonly referred to as \"cradle cap,\" is a frequent condition during the first months of life and may also occur in association with manifestations of seborrheic dermatitis. As part of the non-pharmacological topical management of these manifestations, cosmetic products may be used to help improve visible skin signs without exerting a pharmacological action.\n\nTRIDERM D.S. Crema Normalizzante is a cosmetic product intended for use as a cosmetic adjunct in the presence of manifestations associated with seborrheic dermatitis. In this study, the product will be applied according to a regimen consisting of an intensive phase, with two applications per day for 10 days, followed by a maintenance phase, with two applications per day on 3 days per week for the subsequent two weeks. At the end of the product-use period, a follow-up period without product application is planned.\n\nThere will be no control group or comparator product. Assessments will be performed longitudinally within each participant by comparing the condition observed at baseline with that observed during product use and at follow-up. The overall duration of participation for each participant will be approximately 52 days. The study is exploratory and preliminary in nature and is intended to generate clinical data to support the scientific documentation and cosmetic claims related to the product.",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"TRIDERM D.S. Crema Normalizzante","EXPERIMENTAL","Participants assigned to this single experimental arm will receive the cosmetic product TRIDERM D.S. Crema Normalizzante. The product will be applied twice daily for 10 days during the intensive phase, followed by a maintenance phase consisting of twice-daily application on 3 days per week for the subsequent two weeks. After completion of the product-use period, participants will undergo a 28-day follow-up period without product application.",[52],"Other: TRIDERM D.S. Crema Normalizzante",[54],{"type":55,"name":48,"description":56,"armGroupLabels":57,"otherNames":41},"OTHER","TRIDERM D.S. Crema Normalizzante is a topical cosmetic product intended for use as a cosmetic adjunct in the presence of skin manifestations associated with seborrheic dermatitis. The product will be applied to the affected skin areas according to a two-phase regimen: an intensive phase consisting of two applications per day for 10 consecutive days, followed by a maintenance phase consisting of two applications per day on 3 days per week for the subsequent 2 weeks. After completion of the 24-day product-use period, no further product application will be performed during the 28-day follow-up period.",[48],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":41,"email":63},"Dr. Teresa Oranges, Medical Doctor","CONTACT","+ 39 3334720816","teresa.oranges@meyer.it",{"name":65,"role":61,"phone":41,"phoneExt":41,"email":66},"Dr. Cesare Filippeschi, Medical Doctor","cesare.filippeschi@meyer.it",[68],{"facility":69,"status":41,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Meyer Children's Hospital IRCCS","Florence","Tuscany","50139","Italy","IT",{"type":76,"coordinates":77},"Point",[78,79],11.24626,43.77925,{"lat":79,"lon":78},[82],{"name":60,"role":61,"phone":83,"phoneExt":41,"email":63},"3534857430",{"type":85,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100659198","triderm-ds-crema-normalizzante-for-neonatal-hyperseborrhea-cradle-cap-and-associated-cutaneous-manifestations-of-mild-to-moderate-seborrheic-dermatitis-in-children-aged-0-to-3-years-100659198",false,"NCT07860788","TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years","Prospective, Interventional, Single-Center, Single-Arm Clinical Study to Evaluate the Clinical Improvement of Neonatal Hyperseborrhea (\"Cradle Cap\"), Including Potential Cutaneous Manifestations Associated With Mild-to-Moderate Seborrheic Dermatitis, and the Cutaneous Tolerability of the Cosmetic Product TRIDERM D.S. Crema Normalizzante.","Inclusion Criteria:\n\n* Age from 0 to 3 years.\n* Good general health.\n* Clinical diagnosis of neonatal hyperseborrhea (\"cradle cap\"), including possible cutaneous manifestations associated with mild-to-moderate seborrheic dermatitis.\n* No use of keratolytic, anti-inflammatory, or antifungal treatments within the 15 days prior to enrollment.\n* Written informed consent provided by the participant's parent(s) or legal guardian.\n\nExclusion Criteria:\n\n* Presence of other concomitant dermatological conditions that, in the Investigator's judgment, may interfere with the clinical assessment of the study.\n* Presence of seborrheic dermatitis of greater severity than that specified in the inclusion criteria.\n* Use of specific topical treatments (keratolytics, corticosteroids, or antifungals) on the affected areas within the 15 days prior to enrollment.\n* Participation in another clinical study within the 30 days prior to enrollment.\n* Known or suspected hypersensitivity to one or more components of the study product.","ALL","0 Years","3 Years",{"count":97,"type":98},20,"ESTIMATED","INTERVENTIONAL",[39],"This clinical study aims to evaluate the effects of using the cosmetic product TRIDERM D.S. Crema Normalizzante in children aged 0 to 3 years with neonatal hyperseborrhea (\"cradle cap\"), potentially associated with manifestations of mild-to-moderate seborrheic dermatitis. The study will assess whether use of the product is associated with an improvement in the clinical signs of the condition, particularly scaling and erythema, and will evaluate its cutaneous tolerability. Caregiver-perceived improvement, as well as additional dermatological, photographic, and instrumental assessments, will also be considered.",[103,104],"Cradle Cap","Seborrheic Dermatitis",[106,107,108,109,110,111,112,113,48],"Neonatal hyperseborrhea","Infantile seborrheic dermatitis","Cradle cap","Scaling","Erythema","Pediatric dermatology","Cosmetic product","Cutaneous tolerability","NOT_YET_RECRUITING","2026-09-30",{"date":117,"type":118},"2026-10-06","ACTUAL",{"date":120,"type":98},"2026-10",{"date":122,"type":98},"2027-02",{"name":5,"class":6},1]