Crow's Feet WrinklesPhase 4NCT02497846
TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles
A Phase 4 study testing TEOSYAL® PureSense Redensity [I]/MicronJet® in people with Crow's Feet Wrinkles, run by Teoxane SA at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL® PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet wrinkles. It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with an interval of 3 weeks. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Crow's Feet Wrinkles
- What is being tested?
- TEOSYAL® PureSense Redensity [I]/MicronJet®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer (desiring an aesthetic improvement of crow's feet area).
- Crow's feet score between 3 to 5 on both sides.
- Psychologically able to understand the study related information (For example, it will be difficult to include a foreigner who does not speak French, unaccompanied by a translator or subject who can't read the information note and the volunteer diary).
- Having given his informed consent.
- Female subjects of childbearing potential should use a medically accepted contraceptive regimen (for example, hormonal contraception, intrauterine contraceptive device or surgical sterilization…), during all the study and at least 1 month after the study end.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study (according to the product IFU).
- Volunteer having a previous history of cutaneous cancer or all others type of cancer. (to verify that the volunteer is healthy)
- Suffering from a serious or progressive diseases, which, put the subject at undue risk (as for example diabetes, auto-immune pathology, cardiac pathologies, hepatic deficiency, epilepsy )(to verify that the volunteer is healthy)
- With scars, infection, or other pathology on the injection sites. (as rosacea, herpes, acne, blotches on the injection sites. (the product injection can't be performed on a damaged skin and the wrinkles can be seen by the investigator - according to the product IFU)
- With active skin disease within 6 months prior to study entry. (according to the product IFU)
- With severe rheumatism fever.
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- Predisposed to keloidosis (itchy skin or skin rash and hives) or hypertrophic scarring. (
- With a known allergy to one of the ingredients of the tested products (as hyaluronic acid hypersensitivity or lidocaine or local anesthetic: 70° Alcohol or Chlorhexidine allergy). (according to the product IFU)
- With multiple allergies or anaphylactic shock history. (according to the product IFU)
- With coagulation troubles, abnormal bleeding as hemophiliac or von Willebrand disease.
- Under an anti-coagulant treatment in the 2 weeks preceding the study.
- Under >30,000 IU/day oral vitamin E in the 1 week preceding the study.
- Under corticosteroids in the 2 weeks preceding the study and used in the severe allergy treatment.
- Under interferon in the 1 month preceding the study and used for antiinfectious or antioncogene proprieties.
- Having an aspirin (ASA - Acetyl Salicylic Acid) or a non-steroidal anti-inflammatory treatment in the last 15 days (the subject can still be bled easily).
- Having a peeling, laser or ultrasound-based treatment. (according to the product IFU)
- Having any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety tolerance (currently, the interactions with an other HA product are not tested, it is not possible to inject Teosyal® PureSense Redensity I into sites where other filling implants are present - according to the product IFU).
- Suspected to be non-compliant according to the investigator's judgment (for example, a subject for which the investigator knows that he cannot come to all the visits in reason of holidays or moving, can be not include in this study)
- Enrolled in another clinical trial or being in an exclusion period for a previous study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles
The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL® PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet wrinkles.
It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.
Only, one group of 15 healthy volunteers will be included.
Read the detailed description
TEOSYAL® PureSense Redensity [I] is a viscoelastic gel of non-cross-linked hyaluronic acid that is sterile, non pyrogenic, colourless and of non-animal origin and contains 0.3% by mass of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two syringes pre-filled with Teosyal® PureSense Redensity I. The volume of each syringe is shown on the cardboard box as well as on each syringe. Teosyal® PureSense Redensity I is indicated for the prevention of wrinkles and rehydration of the neck, neckline, face and in particular the crow's feet wrinkles.
The MicronJet® needle is a 3 micro-needle (0.6 mm of length) device that is mounted on a standard syringe in the same manner as a conventional needle. The MicronJet® needle is used to inject liquid substances, allowing for controlled intradermal delivery in any procedure which requires administration of substances to the dermal compartment.
For the first time, the TEOSYAL® PureSense Redensity [I] will be injected using the medical device MicronJet® in the superficial wrinkles.
- Conditions
- Crow's Feet Wrinkles
- Being tested
- TEOSYAL® PureSense Redensity [I]/MicronJet®
- Keywords
- Hyaluronic acid, MiconJet needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL® PureSense Redensity [I]/MicronJet®Device
According the instruction of use, 3 injections of TEOSYAL® PureSense Redensity [I]will be performed all the 3 weeks. The used needle will be the MicronJet® microneedles for product injection. And the last visit (of control) will be performed 3 weeks after the last injection.
| Study group | Role | What they receive |
|---|---|---|
| TEOSYAL® PureSense Redensity [I]/MicronJet® | Experimental | injection of the acid hyaluronic gel with lidocaine as an anesthetic and a "dermo-restructuring complex (including 8 amino acids , 3 antioxidants Acid, vitamin B6 and 2 minerals).
Product will be injected in a unique device group:
* in crow's feet in order to cover the zone to be treated. Quantity of product injected will be determined by the injector and noted (up to 1 ml by side). A subject can be injected in the left or/and right side.
* using a MicronJet microneedle for the superficial wrinkles. Receives: Device: TEOSYAL® PureSense Redensity [I]/MicronJet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crow's feet responder for the feasibility outcome
The crow's feet responder is defined as a crow's feet score with at least one grade of improvement between D0 and D63. As the subject can be treated on each side, each subject can give two answers.
Measured: Day 63 (end of study)
Secondary outcomes (2)
Subject satisfaction for acceptability outcome
5-grade Likert scale
Measured: at Day 0, Day 21, D42 and D63 (end of study visit)
Pain evaluated by the subject
Subjective visual analogue scale (0 to 10 cm)
Measured: at Day 0, Day 21 and D42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's Feet WrinklesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497846
- Sponsor's protocol ID
- TEO-R1-1404
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles
- ClinicalTrials.gov ID
- NCT02497846
- Acronym / sponsor ID
- TEO-R1-1404
- Conditions
- Crow's Feet Wrinkles
- Keywords
- Hyaluronic acid, MiconJet needle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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.
The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL® PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet wrinkles.
It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.
Only, one group of 15 healthy volunteers will be included.
Detailed description
TEOSYAL® PureSense Redensity [I] is a viscoelastic gel of non-cross-linked hyaluronic acid that is sterile, non pyrogenic, colourless and of non-animal origin and contains 0.3% by mass of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two syringes pre-filled with Teosyal® PureSense Redensity I. The volume of each syringe is shown on the cardboard box as well as on each syringe. Teosyal® PureSense Redensity I is indicated for the prevention of wrinkles and rehydration of the neck, neckline, face and in particular the crow's feet wrinkles.
The MicronJet® needle is a 3 micro-needle (0.6 mm of length) device that is mounted on a standard syringe in the same manner as a conventional needle. The MicronJet® needle is used to inject liquid substances, allowing for controlled intradermal delivery in any procedure which requires administration of substances to the dermal compartment.
For the first time, the TEOSYAL® PureSense Redensity [I] will be injected using the medical device MicronJet® in the superficial wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEOSYAL® PureSense Redensity [I]/MicronJet® | Experimental | Device: TEOSYAL® PureSense Redensity [I]/MicronJet®injection of the acid hyaluronic gel with lidocaine as an anesthetic and a "dermo-restructuring complex (including 8 amino acids , 3 antioxidants Acid, vitamin B6 and 2 minerals). Product will be injected in a unique device group: * in crow's feet in order to cover the zone to be treated. Quantity of product injected will be determined by the injector and noted (up to 1 ml by side). A subject can be injected in the left or/and right side. * using a MicronJet microneedle for the superficial wrinkles. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteer (desiring an aesthetic improvement of crow's feet area).
- Crow's feet score between 3 to 5 on both sides.
- Psychologically able to understand the study related information (For example, it will be difficult to include a foreigner who does not speak French, unaccompanied by a translator or subject who can't read the information note and the volunteer diary).
- Having given his informed consent.
- Female subjects of childbearing potential should use a medically accepted contraceptive regimen (for example, hormonal contraception, intrauterine contraceptive device or surgical sterilization…), during all the study and at least 1 month after the study end.
Key exclusion criteria (19 listed)
- Pregnant or nursing woman or planning a pregnancy during the study (according to the product IFU).
- Volunteer having a previous history of cutaneous cancer or all others type of cancer. (to verify that the volunteer is healthy)
- Suffering from a serious or progressive diseases, which, put the subject at undue risk (as for example diabetes, auto-immune pathology, cardiac pathologies, hepatic deficiency, epilepsy )(to verify that the volunteer is healthy)
- With scars, infection, or other pathology on the injection sites. (as rosacea, herpes, acne, blotches on the injection sites. (the product injection can't be performed on a damaged skin and the wrinkles can be seen by the investigator - according to the product IFU)
- With active skin disease within 6 months prior to study entry. (according to the product IFU)
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 |
|---|---|---|
| TEOSYAL® PureSense Redensity [I]/MicronJet®According the instruction of use, 3 injections of TEOSYAL® PureSense Redensity [I]will be performed all the 3 weeks. The used needle will be the MicronJet® microneedles for product injection. And the last visit (of control) will be performed 3 weeks after the last injection. | Device | TEOSYAL® PureSense Redensity [I]/MicronJet® |
Primary outcome
Crow's feet responder for the feasibility outcome
Time frame: Day 63 (end of study)
The crow's feet responder is defined as a crow's feet score with at least one grade of improvement between D0 and D63. As the subject can be treated on each side, each subject can give two answers.
2 secondary outcomes
Subject satisfaction for acceptability outcome
Time frame: at Day 0, Day 21, D42 and D63 (end of study visit)
Pain evaluated by the subject
Time frame: at Day 0, Day 21 and D42
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 8 Apr 2016.
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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 Phase 4 study testing TEOSYAL® PureSense Redensity [I]/MicronJet® in people with Crow's Feet Wrinkles, run by Teoxane SA 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 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 8 Apr 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Crow's feet responder for the feasibility outcome (time frame: Day 63 (end of study)). 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 8 Apr 2016.