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Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650218
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Croma-Pharma GmbH

Study Description
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Brief Summary:

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.

The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.


Condition or disease Intervention/treatment Phase
Correction of Nasolabial Folds Device: THIODERM STRONG Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 23, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: THIODERM STRONG

THIODERM STRONG injected into the upper arm (cohort 1)

THIODERM STRONG injected into nasolabial folds (cohort 2)

 Device: THIODERM STRONG
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1: Frequency, severity, seriousness and causal relationship of AEs [ Time Frame: Up to 4 weeks ]
  2. Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening [ Time Frame: Up to 4 weeks ]
    5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe)

  3. Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment [ Time Frame: Week 12 compared to baseline ]
    Scale from 0 (=none/ minimal) to 4 (= extreme)


Secondary Outcome Measures :
  1. Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) [ Time Frame: Week 4, 24, 36 and 52 compared to baseline ]
    Scale from 0 (=none/ minimal) to 4 (= extreme)

  2. Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator [ Time Frame: Week 4, 12, 24, 36 and 52 compared to baseline ]
    global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'

  3. Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject [ Time Frame: Week 4, 12, 24, 36 and 52 compared to baseline ]
    global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'

  4. Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale [ Time Frame: Week 4, 12, 24, 36 and 52 compared to baseline ]
  5. Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) [ Time Frame: Week 4, 12, 24, 36 and 52 compared to baseline ]
    Scale from 0 (=none/ minimal) to 4 (= extreme)

  6. Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) [ Time Frame: Week 4, 12, 24, 36 and 52 compared to baseline ]
    Scale from 0 (=none/ minimal) to 4 (= extreme)

  7. Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS) [ Time Frame: Immediately after administration and 15 minutes after treatment ]
    11-point scale ranging from 0 (= no pain) to 10 (=worst pain imaginable)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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:

  • For females: pregnant and/ or lactating or planning to become pregnant during the investigation
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650218


Locations
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Austria
Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie
Graz, Austria, 8036
Yuvell
Vienna, Austria, 1010
Sponsors and Collaborators
Croma-Pharma GmbH
More Information
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Responsible Party: Croma-Pharma GmbH
ClinicalTrials.gov Identifier: NCT03650218    
Other Study ID Numbers: CPH-201-201334
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No