Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds
NCT ID: NCT03650218
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2018-07-10
2019-12-23
Brief Summary
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The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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THIODERM STRONG
THIODERM STRONG injected into the upper arm (cohort 1)
THIODERM STRONG injected into nasolabial folds (cohort 2)
THIODERM STRONG
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.
Interventions
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THIODERM STRONG
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Moderate to severe nasolabial folds (cohort 2)
* Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2)
* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
Exclusion Criteria
* History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic
* Tendency to keloid formation and/ or hypertrophic scars
* Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
* Recurrent herpes simplex in the treatment area
* History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
* Diabetes mellitus or uncontrolled systemic diseases
* History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection
* Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator
* Previous enrollment in this clinical investigation
* 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
* Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator
* Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act
* Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2)
* Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2)
* Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2)
* Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2)
* Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2)
* Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)
18 Years
ALL
Yes
Sponsors
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Croma-Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie
Graz, , Austria
Yuvell
Vienna, , Austria
Countries
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Other Identifiers
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CPH-201-201334
Identifier Type: -
Identifier Source: org_study_id