[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659429":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":49,"armGroups":53,"interventions":60,"overallOfficials":70,"centralContacts":85,"locations":93,"responsibleParty":129,"collaborators":131,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":49,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":142,"minAge":143,"maxAge":49,"enrollmentInfo":144,"targetDuration":49,"studyType":147,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":96,"whyStopped":49,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"WiQo S.p.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":39},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in VISIA Pores Score","Objective pore assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer visible pores relative to the reference population and represent a better outcome.","Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)",{"measure":14,"description":15,"timeFrame":12},"Change in VISIA Spots Score","Objective spot assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer visible spots relative to the reference population and represent a better outcome.",{"measure":17,"description":18,"timeFrame":12},"Change in VISIA Red Areas Score","Objective assessment of red area extent performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ) using RBX® Red channel imaging. The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate reduced surface redness relative to the reference population and represent a better outcome.",{"measure":20,"description":21,"timeFrame":12},"Change in VISIA Porphyrins Score","Objective porphyrin assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ) using UV fluorescence photography. The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer porphyrins relative to the reference population and represent a better outcome.",{"measure":23,"description":24,"timeFrame":12},"Change in VISIA Texture Score","Objective skin texture assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate smoother skin texture relative to the reference population and represent a better outcome.",[26,29,32,35],{"measure":27,"description":28,"timeFrame":12},"Change in Investigator Global Assessment (IGA) Score","Clinician-rated acne severity assessed using the Investigator Global Assessment (IGA) scale, a 5-point ordinal scale ranging from 0 to 4 (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe). Lower scores indicate less severe acne and represent a better outcome. The T0 value serves as individual reference.",{"measure":30,"description":31,"timeFrame":12},"Change in Global Acne Grading System (GAGS) Score","Clinician-rated acne severity assessed using the Global Acne Grading System (GAGS), a weighted scoring instrument that evaluates acne lesion type and distribution across six facial and truncal regions (forehead, right cheek, left cheek, nose, chin, and chest\u002Fback). Total scores range from 0 to 44: 0 = no acne; 1-18 = mild; 19-30 = moderate; 31-38 = severe; \\>38 = very severe. Lower scores indicate less severe acne and represent a better outcome. The T0 value serves as individual reference.",{"measure":33,"description":34,"timeFrame":12},"Change in Quality of Life Relevance-Acne (QoL-RA) Score","Participant-reported acne-related quality of life assessed using the Quality of Life Relevance-Acne (QoL-RA) questionnaire (Chernyshov et al., JAAD International, 2024). The QoL-RA is a 19-item self-reported instrument covering 3 dimensions: Socioemotional (11 items), Symptoms (4 items), and Stigma and Suicidal thoughts (4 items). Each item is rated on a 4-point scale (0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently); total scores range from 0 to 57. Higher scores indicate greater HRQoL impairment and represent a worse outcome.",{"measure":36,"description":37,"timeFrame":38},"Treatment Tolerability","Incidence and type of adverse events and product-related tolerability findings across all 5 treatment sessions.","Through study completion (Week 10)",[40,43],{"measure":41,"description":42,"timeFrame":12},"VISIA Acne-Prone Skin Composite Index (VISIA-APS)","Pre-specified composite summary index computed as the mean of the z-scores of the five principal VISIA parameters (pores, spots, red areas, porphyrins, and texture), standardized using the sample mean and SD at baseline (T0). The direction of each z-score is pre-specified so that positive values consistently indicate improvement. The VISIA-APS has no fixed minimum or maximum; higher values indicate greater overall improvement across all five acne-prone skin parameters and represent a better outcome.",{"measure":44,"description":45,"timeFrame":12},"VISIA Wrinkles Score","Objective wrinkle assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer visible wrinkles relative to the reference population. This parameter is reported descriptively only and is not included in formal inferential analyses.",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":49,"timePerspective":49,"maskingInfo":51},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":52,"maskingDescription":49,"whoMasked":49},"NONE",[54],{"label":55,"type":56,"description":49,"interventionNames":57},"PRX S Cosmetic Treatment with Home Care Regimen","EXPERIMENTAL",[58,59],"Other: PRX S topical cosmetic treatment","Other: WiQo home care regimen (Nourishing Cream; Balancing Cream)",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":49},"OTHER","PRX S topical cosmetic treatment","PRX S (WiQo SpA, Milan, Italy) is a topical cosmetic formulation designed for acne-prone and oily skin. It is applied in-office by trained aesthetic professionals or dermatologists using a proprietary non-ablative technique with no visible peeling or downtime. Five sessions are administered at two-week intervals (Weeks 0, 2, 4, 6, 8). The application procedure is adapted to the participant's skin presentation: Procedure 1 for oily skin with enlarged pores; Procedure 2 for comedone-predominant presentations. PRX S is supplied directly to study sites by the Sponsor free of charge.",[55],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":49},"WiQo home care regimen (Nourishing Cream; Balancing Cream)","A standardized daily home care regimen prescribed in conjunction with in-office PRX S sessions, consisting of two commercially available cosmetic products supplied by the Sponsor: WiQo Nourishing Cream for Normal and Combination Skin (applied each morning) and WiQo Balancing Cream (applied each evening). The Balancing Cream contains micronized azelaic acid, encapsulated salicylic acid, fermented botanical extracts, and niacinamide. Both products are supplied to participants free of charge for the duration of the study.",[55],[71,75,79,82],{"name":72,"affiliation":73,"role":74},"Maria Luisa Garo","Mathsly Research","STUDY_DIRECTOR",{"name":76,"affiliation":77,"role":78},"Kathy Gaumer, MD","Regain Functional Medicine and Aesthetics, Leawood, KS","PRINCIPAL_INVESTIGATOR",{"name":80,"affiliation":81,"role":78},"Kesha Buster, MD","VibrantSkin Dermatology and Laser, Tulsa, OK",{"name":83,"affiliation":5,"role":84},"Deborah Subissati","STUDY_CHAIR",[86,90],{"name":83,"role":87,"phone":88,"phoneExt":49,"email":89},"CONTACT","+39 040360408","deborah.subissati@wiqo.eu",{"name":72,"role":87,"phone":91,"phoneExt":49,"email":92},"+393774326165","marilu.garo@mathsly.it",[94,114],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Regain Functional Medicine and Aesthetics","RECRUITING","Leawood","Kansas","66211","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-94.6169,38.96667,{"lat":106,"lon":105},[109,112],{"name":76,"role":87,"phone":110,"phoneExt":49,"email":111},"913-291-8555","kathy.gaumer@gmail.com",{"name":113,"role":78,"phone":49,"phoneExt":49,"email":49},"Kathy Gaumer",{"facility":115,"status":96,"city":116,"state":117,"zip":118,"country":100,"countryCode":101,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"VibrantSkin Dermatology and Laser","Tulsa","Oklahoma","74137",{"type":103,"coordinates":120},[121,122],-95.99277,36.15398,{"lat":122,"lon":121},[125,128],{"name":80,"role":87,"phone":126,"phoneExt":49,"email":127},"918-340-6539","drbuster@vibrantskintulsa.com",{"name":80,"role":78,"phone":49,"phoneExt":49,"email":49},{"type":130,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[132],{"name":73,"class":133},"UNKNOWN","100659429","observational-assessment-of-skin-appearance-changes-during-prx-s-cosmetic-treatment-in-participants-with-acne-prone-skin-100659429",false,"NCT07866131","Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin","Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin: A Multicenter Pilot Cohort Pre-Post Study","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent.\n* Presence of acne-prone skin characteristics defined as an IGA score of 1 (almost clear) to 3 (moderate) at baseline (T0).\n* Willing and able to commit to 5 in-office treatment sessions at approximately 2-week intervals over approximately 8 weeks, plus one follow-up visit at Week 10.\n* Willing to discontinue all current skincare products and adhere exclusively to the WiQo standardized home care regimen throughout the study period. The participant's current skincare regimen must be, in the investigator's judgment, safe to discontinue on the day of the first treatment session without requiring a prior washout period.\n* Able to understand and willing to sign the informed consent form prior to any study procedure.\n* In general good health as determined by medical history and investigator judgment.\n* Ability to read and understand English at a level sufficient to provide written informed consent and complete all study questionnaires independently.\n\nExclusion Criteria:\n\n* IGA score of 0 (clear) or 4 (severe) at baseline.\n* Active skin infection, open wounds, or acute inflammatory dermatological conditions in the facial treatment area at the time of enrollment.\n* History of hypersensitivity or known allergy to any component of the PRX S formulation or the WiQo home care products.\n* Use of systemic retinoids within 6 months prior to enrollment.\n* Use of systemic antibiotics for acne within 4 weeks prior to enrollment.\n* Ongoing use of topical prescription acne medications (retinoids, topical antibiotics, dapsone) that the participant is unwilling or unable to discontinue.\n* Pregnancy, breastfeeding, or planned pregnancy during the study period. Pregnancy status is determined by participant self-report at screening and confirmed through the signed Informed Consent Form, in which the participant acknowledges that pregnancy constitutes a contraindication to the study treatment.\n* Prior cosmetic or aesthetic treatment of the face (chemical peel, laser, microneedling, injectables) within 4 weeks prior to enrollment, or prior treatment of the chest or back within 4 weeks prior to enrollment that, in the investigator's judgment, could confound GAGS assessments.\n* Any active medical condition that, in the investigator's judgment, could confound study assessments or place the participant at undue risk.\n* Participation in another interventional clinical study within 30 days prior to enrollment.\n* Inability or unwillingness to comply with study procedures and follow-up requirements.",true,"ALL","18 Years",{"count":145,"type":146},30,"ESTIMATED","INTERVENTIONAL",[47],"This pilot cohort study evaluates changes in skin surface appearance in adult participants with acne-prone skin during and following a standardized five-session course of PRX S (WiQo SpA), a topical cosmetic product designed for oily and acne-prone skin.\n\nThe study asks whether a standardized in-office PRX S treatment cycle - five sessions administered at two-week intervals and complemented by a prescribed home care regimen - is associated with observable changes in objective skin surface parameters (pore appearance, texture, spots, redness, porphyrins), clinician-rated acne severity (IGA, GAGS), and participant-reported skin-related quality of life (QoL-RA) in adults with acne-prone skin.\n\nUsing a single-group, pre-post observational design across two U.S. sites (Leawood, KS and Tulsa, OK), 30 participants will undergo VISIA complexion analysis and clinical assessments at baseline (T0), mid-cycle (T1, Week 6), and end of follow-up (T2, Week 10). No single primary endpoint is designated; all analyses are explicitly exploratory.",[151,152],"Acne-prone Skin","Skin Disease",[154,155,156,157,158,159],"acne-prone skin","skin condition","cosmetics","pore refinement","quantitative evaluation","quality of life","2026-10-06",{"date":162,"type":163},"2026-10-08","ACTUAL",{"date":165,"type":163},"2026-09-21",{"date":167,"type":146},"2026-12",{"name":5,"class":6},2]