Skin AgingNCT05349799
TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines
A study testing TEOSYAL RHA® 1, TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle) and TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula) in people with Skin Aging and Fine Lines of the Face and Neck, run by Teoxane SA at 4 sites in Spain.
Trial summary
Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, and smiling lines including an exploratory arm with TEOSYAL® PureSense Redensity 1 to assess skin redensification. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Fine Lines of the Face and Neck
- What is being tested?
- TEOSYAL RHA® 1, TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle) and TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesSpain
- Study dates
- 5 Oct 2021to 31 May 2022
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults, 35 to 70 years old seeking an improvement of their aesthetic appearance and beautification of their skin in 3 areas: perioral lines, smiling lines and neck lines.
- Subjects having given their informed consent.
- Subjects having wrinkle severity ranked as mild to moderate neck lines (grade 2 or grade 3 on the NLDS)
- Inclusion Criteria (Cohort) 4. Healthy adult having wrinkle severity in at least one of the two indications (50% for each of the following cohort): i. Moderate to severe perioral rhytids (grade 2 or grade 3 on the PR-SRS) ii. Moderate to severe smiling lines (grade 3 or grade 4 on the SLDS)
Who cannot join
- Minor subjects
- Subjects who already had fillers and/or other skin quality treatment(s) in the 6 months preceding the study.
- Subjects undergoing or planning to undergo peeling treatment or laser/ultrasound-based treatment during the study or having had one of these treatments in the 6 months preceding the study.
- Subjects showing cutaneous disorders, inflammation or infection (acne, herpes, scars…) at the treatment site or near to this site.
- Subjects having a known hypersensibility to lidocaine and/or amide local anesthetic agents or hyaluronic acid, or with history of severe allergy or anaphylactic shock.
- Subjects with autoimmune or cardiac diseases and/or undergoing treatment for heart diseases (beta blockers).
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- Subjects with hepatocellular insufficiency and/or undergoing treatment for liver disease.
- Subjects suffering from epilepsy or porphyria.
- Subjects with severe, ongoing and/or uncontrolled disease that may pose a health risk to the subject during the study and/or may have an impact on the study assessments.
- Subjects receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection.
- Subjects receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject at undue risk.
- Subjects under guardianship/tutorship.
- Pregnant women or breastfeeding mother.
- Subjects participating to another research on human beings or being in an exclusion period for a previous study.
Trial locations and contacts
4 sites in 1 country.
About this study
Official title: A Prospective, Multicentric, Open-labelled, Interventional Study to Assess Skin Beautification by Treating Fine Lines in the Neck, Perioral and Smiling Lines Areas With TEOSYAL RHA® 1
Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, and smiling lines including an exploratory arm with TEOSYAL® PureSense Redensity 1 to assess skin redensification.
Treatment phase - skin beautification:
Read more
At Visit 1 (Baseline), subjects will be injected with TEOSYAL RHA® 1 in the fine lines (Neck lines and Perioral and/or Smiling lines) depending on wrinkle severity assessed by the Principal Investigator (PI) at baseline using a specific grading scale for each indication.
The subject will be included in the study if he has been graded 2 or 3 on the Neck Lines Descriptive Scale (NLDS) at baseline.
Then:
- The subject will be included in the perioral rhytids cohort if he has been graded 2 or 3 on the Perioral Rhytids Severity Rating Scale (PR-SRS) at baseline.
- The subject will be included in the smiling lines cohort if he has been graded 3 or 4 on the Smiling Lines Descriptive Scale (SLDS) at baseline.
Each indication represent one cohort and all subjects will be included in the neck lines cohort.
Thus, Subject participating to the study may be treated for:
- Neck Lines and perioral Lines (2 cohorts)
- Neck Lines and Smiling Lines (2 cohorts)
- Neck Lines, Perioral Lines and Smiling Lines (3 cohorts)
An optional touch-up will be performed at Visit 2 (Month 1 +/- 1 week) if deemed necessary to achieve an optimal correction.
Exploratory phase - skin redensification:
After treatment with TEOSYAL RHA® 1, subjects will be randomized to the second phase of the study (starting at month 2 +/- 1 week): 5/6 of the subjects will enter the exploratory part of the study during which TEOSYAL® PureSense Redensity 1 (RHA1+R1 treated Group) will be assessed for skin redensification. The rest of the subjects will not receive any additional treatment for the rest of the study (RHA1 only treated group/around 11 subjects).
Note: the number of sessions treated with Redensity 1 might be adapted depending on subject treatment needs in order to achieve optimal results. This will be at PI discretion.
Subjects in the RHA+R1 treated Group will be also randomized into 2 subgroups of 28 subjects as described below:
- Sub-Group A: injection with a needle for all indications
- Sub-Group B: injection with a cannula for neck lines and smiling lines indications* *The perioral indication will be treated with a needle for this group.
The principal investigator (PI) will perform the study injections. He will evaluate subject aesthetic improvement using grading scales and skin quality measurements at each study visits and assess safety and tolerability of the devices during the study. Adverse events will be monitored by the Clinical Research Associate (CRA) throughout the study.
Additionally, a Blinded Evaluator will also evaluate subject aesthetic improvement using grading scales for each follow-up visits based on photographs.
- Conditions
- Skin Aging, Fine Lines of the Face and Neck
- Being tested
- TEOSYAL RHA® 1, TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle), TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL RHA® 1Device
During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2).
In the exploratory phase of the study, subjects will not receive any additional treatment.
TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle)Device
During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2).
In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a needle. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5).
TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)Device
During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2).
In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a cannula. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5).
| Study group | Role | What they receive |
|---|---|---|
| TEOSYAL RHA® 1 | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, not further treated with TEOSYAL® PureSense Redensity 1 during the "skin redensification" phase. Receives: Device: TEOSYAL RHA® 1 |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a needle | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a needle during the "skin redensification" phase. Receives: Device: TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle) |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a cannula | Experimental | Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a cannula (optional for perioral lines) during the "skin redensification" phase. Receives: Device: TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to both the Principal Investigator (PI) and the subject.
The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
Measured: Visit 3 (Month 2)
Secondary outcomes (3)
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Principal Investigator (PI)
The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
Measured: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the subject
The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
Measured: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Blinded Evaluator (BE)
The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
Measured: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start5 Oct 2021
- Primary completion13 Dec 2021
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349799
- Sponsor's protocol ID
- TEO-RHAR1-2005
- Status last verified
- May 2022
- First submitted
- 20 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Open-labelled, Interventional Study to Assess Skin Beautification by Treating Fine Lines in the Neck, Perioral and Smiling Lines Areas With TEOSYAL RHA® 1
- ClinicalTrials.gov ID
- NCT05349799
- Acronym / sponsor ID
- TEO-RHAR1-2005
- Conditions
- Skin Aging, Fine Lines of the Face and Neck
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 27 Apr 2022 (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.
Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, and smiling lines including an exploratory arm with TEOSYAL® PureSense Redensity 1 to assess skin redensification.
Treatment phase - skin beautification:
At Visit 1 (Baseline), subjects will be injected with TEOSYAL RHA® 1 in the fine lines (Neck lines and Perioral and/or Smiling lines) depending on wrinkle severity assessed by the Principal Investigator (PI) at baseline using a specific grading scale for each indication.
The subject will be included in the study if he has been graded 2 or 3 on the Neck Lines Descriptive Scale (NLDS) at baseline.
Then:
- The subject will be included in the perioral rhytids cohort if he has been graded 2 or 3 on the Perioral Rhytids Severity Rating Scale (PR-SRS) at baseline.
- The subject will be included in the smiling lines cohort if he has been graded 3 or 4 on the Smiling Lines Descriptive Scale (SLDS) at baseline.
Each indication represent one cohort and all subjects will be included in the neck lines cohort.
Thus, Subject participating to the study may be treated for:
- Neck Lines and perioral Lines (2 cohorts)
- Neck Lines and Smiling Lines (2 cohorts)
- Neck Lines, Perioral Lines and Smiling Lines (3 cohorts)
An optional touch-up will be performed at Visit 2 (Month 1 +/- 1 week) if deemed necessary to achieve an optimal correction.
Exploratory phase - skin redensification:
After treatment with TEOSYAL RHA® 1, subjects will be randomized to the second phase of the study (starting at month 2 +/- 1 week): 5/6 of the subjects will enter the exploratory part of the study during which TEOSYAL® PureSense Redensity 1 (RHA1+R1 treated Group) will be assessed for skin redensification. The rest of the subjects will not receive any additional treatment for the rest of the study (RHA1 only treated group/around 11 subjects).
Note: the number of sessions treated with Redensity 1 might be adapted depending on subject treatment needs in order to achieve optimal results. This will be at PI discretion.
Subjects in the RHA+R1 treated Group will be also randomized into 2 subgroups of 28 subjects as described below:
- Sub-Group A: injection with a needle for all indications
- Sub-Group B: injection with a cannula for neck lines and smiling lines indications* *The perioral indication will be treated with a needle for this group.
The principal investigator (PI) will perform the study injections. He will evaluate subject aesthetic improvement using grading scales and skin quality measurements at each study visits and assess safety and tolerability of the devices during the study. Adverse events will be monitored by the Clinical Research Associate (CRA) throughout the study.
Additionally, a Blinded Evaluator will also evaluate subject aesthetic improvement using grading scales for each follow-up visits based on photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEOSYAL RHA® 1 | Experimental | Device: TEOSYAL RHA® 1Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, not further treated with TEOSYAL® PureSense Redensity 1 during the "skin redensification" phase. |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a needle | Experimental | Device: TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle)Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a needle during the "skin redensification" phase. |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a cannula | Experimental | Device: TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)Subjects injected with TEOSYAL RHA® 1 during the "skin beautification" phase, further treated with TEOSYAL® PureSense Redensity 1 using a cannula (optional for perioral lines) during the "skin redensification" phase. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults, 35 to 70 years old seeking an improvement of their aesthetic appearance and beautification of their skin in 3 areas: perioral lines, smiling lines and neck lines.
- Subjects having given their informed consent.
- Subjects having wrinkle severity ranked as mild to moderate neck lines (grade 2 or grade 3 on the NLDS)
- Inclusion Criteria (Cohort) 4. Healthy adult having wrinkle severity in at least one of the two indications (50% for each of the following cohort): i. Moderate to severe perioral rhytids (grade 2 or grade 3 on the PR-SRS) ii. Moderate to severe smiling lines (grade 3 or grade 4 on the SLDS)
Key exclusion criteria (14 listed)
- Minor subjects
- Subjects who already had fillers and/or other skin quality treatment(s) in the 6 months preceding the study.
- Subjects undergoing or planning to undergo peeling treatment or laser/ultrasound-based treatment during the study or having had one of these treatments in the 6 months preceding the study.
- Subjects showing cutaneous disorders, inflammation or infection (acne, herpes, scars…) at the treatment site or near to this site.
- Subjects having a known hypersensibility to lidocaine and/or amide local anesthetic agents or hyaluronic acid, or with history of severe allergy or anaphylactic shock.
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 RHA® 1During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will not receive any additional treatment. | Device | TEOSYAL RHA® 1 |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle)During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a needle. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5). | Device | TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a needle |
| TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a cannula. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5). | Device | TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 with a cannula |
Primary outcome
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to both the Principal Investigator (PI) and the subject.
Time frame: Visit 3 (Month 2)
The Global Aesthetic Improvement Scale (GAIS) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
3 secondary outcomes
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Principal Investigator (PI)
Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the subject
Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to the Blinded Evaluator (BE)
Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit (Month 3), Visit 5 (Month 4), Visit 6 (Month 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEOSYAL RHA® 1, TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle) and TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula) in people with Skin Aging and Fine Lines of the Face and Neck, run by Teoxane SA at 4 sites in Spain.
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
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?
Proportion of subjects improved or much improved on the Global Aesthetic Improvement Scale (GAIS) according to both the Principal Investigator (PI) and the subject. (time frame: Visit 3 (Month 2)). 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 4 May 2022.