Aesthetic DermatologyNCT06142643
Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol
A study testing Dermal Filler Device in people with Aesthetic Dermatology, run by Kylane Laboratoires at 1 site in Switzerland.
Trial summary
Evaluation of safety and performance of HA based injectable device for skin quality improvement Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Dermatology
- What is being tested?
- Dermal Filler Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Dec 2023to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subject.
- Sex: male or female.
- Age: between 35 and 70 years.
- Subject seeking an improvement for HA skin quality improvement product.
- Subject with BMI <30.
- Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
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- Subject having given his/her free, express, and informed consent.
- Subject psychologically able to understand the information related to the study, and to give their written informed consent.
- Subject registered with a social security scheme.
- Women of childbearing potential should use a contraceptive method considered effective since at least 12 weeks and throughout the study
Who cannot join
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject having received a total of 6.000 euros as compensations for their participation in clinical research in the last 12 months, including their participation in the present study.
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- Subject enrolled in another study or whose non-enrollment period is not over.
- Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up…). In terms of associated pathology
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria …) in the 6 months before screening visit.
- Subject with a history of streptococcal disease or an active streptococcus infection.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment
Evaluation of safety and performance of HA based injectable device for skin quality improvement
Read the detailed description
The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.
The secondary objectives of the study are to collect data on:
- the effectiveness four months (M4) after treatment.
- the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
- subject's satisfaction and subject's opinion on aesthetic improvement.
- the injector's satisfaction on the injection quality.
- the safety using clinical evaluation of the Injection Site Reactions (ISR).
- Conditions
- Aesthetic Dermatology
- Being tested
- Dermal Filler Device
- Keywords
- Aesthetic, dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal Filler DeviceDevice
Injection of the device by investigators according to the IFU
| Study group | Role | What they receive |
|---|---|---|
| Device under investigation | Experimental | Not described Receives: Device: Dermal Filler Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance at 1 Month Investigator Overall VISCOL Range
Primary endpoint was the percentage of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%.
Measured: 1 month
Secondary outcomes (8)
Performance at 4 Months Investigator Overall VISCOL Range
Percentage of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole VISCOL range.
Measured: 4 months
Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range
Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS investigator (N=95 indications).
Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by an independent investigator.
Measured: 1 month & 4 months
Performance at 1 & 4 Months Subject Overall VISCOL Range
Percentage of responders for the whole VISCOL range as assessed by the subject. This percentage of responders was compared to a theoretical proportion of 60%
Measured: 1 month, 4 months
Percentage of Indications With Response: GAIS Subject Overall VISCOL Range
Responder rate for the whole indication of VISCOL range at M1 and M4- GAIS subject (N=95 indications) Percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range as assessed by the subject.
Measured: 1 month & 4 months
Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range
Responder rate for the whole VISCOL range by indication at M1 and M4- GAIS combined score (investigator and subjects) (N=95 indications).
It represents the percentage of responders (subjects with a GAIS "Very Much Improved", "Much Improved" or "Improved") for the whole VISCOL range by indication as assessed by the subject as well as by the investigator.
Measured: 1 month & 4 months
Injector Satisfaction Questionnaire Viscol
Distribution of each item of the questionnaire answered by the injectors. For each item of the injector questionnaire, the percentage of answers "very satisfied" and satisfied were computed as "Satisfied" and the percentage of answers "Neither satisfied" ,or "dissatisfied", "dissatisfied" and "very dissatisfied" were computed as Dissatisfied.
The measure reported is the percentage of participants who were "Satisfied".
Measured: D0 (Immediatly after injection)
Subject Satisfaction Questionnaire Viscol
Distribution of each item of the questionnaire answered by the subjects injected with Viscol. For each item of the subject questionnaire, the percentage of answers "totally agree" and "agree" were computed as "Agree" and the percentage of answers "Neither agree and disagree",or "disagree" and "totally disagree" and "very dissatisfied" were computed as "Disagree".
The measure reported is the percentage of participants who "Agree".
Measured: 1 month, 4 months
Percentage of Participants Experiencing Adverse Events
Percentage of participants who experienced at least one Adverse Event (AE), Adverse Device Effect (ADE), and/or Serious Adverse Event (SAE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start8 Dec 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aesthetic DermatologyStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kylane Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142643
- Sponsor's protocol ID
- 23E1077
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2023
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Clinical Evaluation of Range of Injectable Medical Devices Viscol in Aesthetic Treatment
- ClinicalTrials.gov ID
- NCT06142643
- Acronym / sponsor ID
- 23E1077
- Conditions
- Aesthetic Dermatology
- Keywords
- Aesthetic, dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kylane LaboratoiresIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and performance of HA based injectable device for skin quality improvement
Detailed description
The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.
The secondary objectives of the study are to collect data on:
- the effectiveness four months (M4) after treatment.
- the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
- subject's satisfaction and subject's opinion on aesthetic improvement.
- the injector's satisfaction on the injection quality.
- the safety using clinical evaluation of the Injection Site Reactions (ISR).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device under investigation | Experimental | Device: Dermal Filler Device |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy Subject.
- Sex: male or female.
- Age: between 35 and 70 years.
- Subject seeking an improvement for HA skin quality improvement product.
- Subject with BMI <30.
Key exclusion criteria (13 listed)
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject suspected to be non-compliant according to the investigator's judgment.
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 |
|---|---|---|
| Dermal Filler DeviceInjection of the device by investigators according to the IFU | Device | Device under investigation |
Primary outcome
Performance at 1 Month Investigator Overall VISCOL Range
Time frame: 1 month
Primary endpoint was the percentage of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the GAIS (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 60%.
8 secondary outcomes
Performance at 4 Months Investigator Overall VISCOL Range
Time frame: 4 months
Percentage of Indications With Response: GAIS Investigator Overall VISCOL Range
Time frame: 1 month & 4 months
Performance at 1 & 4 Months Subject Overall VISCOL Range
Time frame: 1 month, 4 months
Percentage of Indications With Response: GAIS Subject Overall VISCOL Range
Time frame: 1 month & 4 months
Percentage of Responder With Response: GAIS Investigator by Indication Overall VISCOL Range
Time frame: 1 month & 4 months
Injector Satisfaction Questionnaire Viscol
Time frame: D0 (Immediatly after injection)
Subject Satisfaction Questionnaire Viscol
Time frame: 1 month, 4 months
Percentage of Participants Experiencing Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal Filler Device in people with Aesthetic Dermatology, run by Kylane Laboratoires at 1 site in Switzerland.
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 10 inclusion and 13 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Performance at 1 Month Investigator Overall VISCOL Range (time frame: 1 month). 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 27 Aug 2025.