Correction of Nasolabial FoldsNCT03650218
Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds
A study testing THIODERM STRONG in people with Correction of Nasolabial Folds, run by Croma-Pharma GmbH at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- THIODERM STRONG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesAustria
- Study dates
- 10 Jul 2018to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie
Graz, 8036
Yuvell
Vienna, 1010
About this study
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.
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.
- Conditions
- Correction of Nasolabial Folds
- Being tested
- THIODERM STRONG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THIODERM STRONGDevice
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.
| Study group | Role | What they receive |
|---|---|---|
| THIODERM STRONG | Experimental | THIODERM STRONG injected into the upper arm (cohort 1)
THIODERM STRONG injected into nasolabial folds (cohort 2) Receives: Device: THIODERM STRONG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Frequency, severity, seriousness and causal relationship of AEs
Measured: Up to 4 weeks
Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening
5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe)
Measured: Up to 4 weeks
Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment
Scale from 0 (=none/ minimal) to 4 (= extreme)
Measured: Week 12 compared to baseline
Secondary outcomes (7)
Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
Scale from 0 (=none/ minimal) to 4 (= extreme)
Measured: Week 4, 24, 36 and 52 compared to baseline
Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator
global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'
Measured: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject
global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse'
Measured: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale
Measured: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
Scale from 0 (=none/ minimal) to 4 (= extreme)
Measured: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
Scale from 0 (=none/ minimal) to 4 (= extreme)
Measured: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)
11-point scale ranging from 0 (= no pain) to 10 (=worst pain imaginable)
Measured: Immediately after administration and 15 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start10 Jul 2018
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correction of Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650218
- Sponsor's protocol ID
- CPH-201-201334
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2018
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03650218
- Acronym / sponsor ID
- CPH-201-201334
- Conditions
- Correction of Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THIODERM STRONG | Experimental | Device: THIODERM STRONGTHIODERM STRONG injected into the upper arm (cohort 1) THIODERM STRONG injected into nasolabial folds (cohort 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THIODERM STRONGSoft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance. | Device | THIODERM STRONG |
Primary outcome
Cohort 1: Frequency, severity, seriousness and causal relationship of AEs
Time frame: Up to 4 weeks
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)
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)
7 secondary outcomes
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
Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator
Time frame: Week 4, 12, 24, 36 and 52 compared to baseline
Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject
Time frame: Week 4, 12, 24, 36 and 52 compared to baseline
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
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
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
Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)
Time frame: Immediately after administration and 15 minutes after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THIODERM STRONG in people with Correction of Nasolabial Folds, run by Croma-Pharma GmbH at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Frequency, severity, seriousness and causal relationship of AEs (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.