Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT03650218
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1: Frequency, severity, seriousness and causal relationship of AEs', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening', 'timeFrame': 'Up to 4 weeks', 'description': '5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe)'}, {'measure': "Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment", 'timeFrame': 'Week 12 compared to baseline', 'description': 'Scale from 0 (=none/ minimal) to 4 (= extreme)'}], 'secondaryOutcomes': [{'measure': "Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)", 'timeFrame': 'Week 4, 24, 36 and 52 compared to baseline', 'description': 'Scale from 0 (=none/ minimal) to 4 (= extreme)'}, {'measure': 'Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator', 'timeFrame': 'Week 4, 12, 24, 36 and 52 compared to baseline', 'description': "global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'"}, {'measure': 'Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject', 'timeFrame': 'Week 4, 12, 24, 36 and 52 compared to baseline', 'description': "global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'"}, {'measure': 'Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale', 'timeFrame': 'Week 4, 12, 24, 36 and 52 compared to baseline'}, {'measure': "Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)", 'timeFrame': 'Week 4, 12, 24, 36 and 52 compared to baseline', 'description': 'Scale from 0 (=none/ minimal) to 4 (= extreme)'}, {'measure': "Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)", 'timeFrame': 'Week 4, 12, 24, 36 and 52 compared to baseline', 'description': 'Scale from 0 (=none/ minimal) to 4 (= extreme)'}, {'measure': 'Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Immediately after administration and 15 minutes after treatment', 'description': '11-point scale ranging from 0 (= no pain) to 10 (=worst pain imaginable)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Correction of Nasolabial Folds']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open label, dose-escalating, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM STRONG in the correction of nasolabial folds.\n\nThe performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females of childbearing potential must have a negative urine pregnancy test at Screening/ Baseline visit and must agree to use an adequate method of contraception for the duration of the clinical investigation\n* Signed informed consent\n* Moderate to severe nasolabial folds (cohort 2)\n* Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2)\n* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation\n\nExclusion Criteria:\n\n* For females: pregnant and/ or lactating or planning to become pregnant during the investigation\n* History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic\n* Tendency to keloid formation and/ or hypertrophic scars\n* Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated\n* Recurrent herpes simplex in the treatment area\n* History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy\n* Diabetes mellitus or uncontrolled systemic diseases\n* History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection\n* Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator\n* Previous enrollment in this clinical investigation\n* Current participation in another clinical investigation, or treatment with any investigational drug/ medical device within 30 days prior to clinical investigation enrollment, or five half-lives of the investigational drug, whichever is longer\n* Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator\n* Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act\n* Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2)\n* Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2)\n* Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2)\n* Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2)\n* Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2)\n* Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)'}, 'identificationModule': {'nctId': 'NCT03650218', 'briefTitle': 'Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Croma-Pharma GmbH'}, 'officialTitle': 'A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.', 'orgStudyIdInfo': {'id': 'CPH-201-201334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THIODERM STRONG', 'description': 'THIODERM STRONG injected into the upper arm (cohort 1)\n\nTHIODERM STRONG injected into nasolabial folds (cohort 2)', 'interventionNames': ['Device: THIODERM STRONG']}], 'interventions': [{'name': 'THIODERM STRONG', 'type': 'DEVICE', 'description': 'Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.', 'armGroupLabels': ['THIODERM STRONG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1010', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Yuvell', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Croma-Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}