Lower Face Folds and LinesNCT04520997
Restylane Defyne in a Stepwise Treatment Approach
A study testing Restylane Defyne in people with Lower Face Folds and Lines, run by Galderma R&D at 5 sites in 3 countries.
Trial summary
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lower Face Folds and Lines
- What is being tested?
- Restylane Defyne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 7 Dec 2020to 15 Sep 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects willed to comply with the requirements of the study and provided a signed written informed consent
- Subjects willed to undergo augmentation and correction therapy in the studied indications
- Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
- Participation in any interventional clinical study within 30 days of screening
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Galderma Research Site
Birmingham, Alabama, 35209
Galderma Research Site
Chicago, Illinois, 60611
Brazil2 sites
Galderma Research Site
Belo Horizonte
Galderma Research Site
São Paulo
About this study
Official title: A Randomized, Evaluator-Blinded Study to Evaluate Facial Harmony and Subject Satisfaction Using Restylane Defyne in a Stepwise Treatment Approach
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
- Conditions
- Lower Face Folds and Lines
- Being tested
- Restylane Defyne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane DefyneDevice
Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.
Restylane DefyneDevice
Up to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.
| Study group | Role | What they receive |
|---|---|---|
| Down-up | Experimental | Participants in this group received up to 2 mL Restylane Defyne on chin at baseline and up to 2 mL of Restylane Defyne per NLF at baseline and up to 2 mL per ML of Restylane Defyne at Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. Receives: Device: Restylane Defyne |
| Top-down | Experimental | Participants in this group received up to 2 mL Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at baseline and up to 2mL on chin Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. Receives: Device: Restylane Defyne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.
Measured: At Week 3
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported.
Measured: At Week 6
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.
Measured: At Week 9
Secondary outcomes (2)
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: "The treatment results were natural looking". The investigator's questionnaire for naturalness of the treatment result were categorized into "strongly agree, agree, neither agree or disagree, disagree and strongly disagree". The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported.
Measured: At Week 3, 6, and 9
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported.
Measured: At Week 3, 6 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start7 Dec 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
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 Lower Face Folds and LinesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520997
- Sponsor's protocol ID
- 05DF1910
- Status last verified
- Apr 2023
- First submitted
- 17 Aug 2020
- Last updated
- 14 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded Study to Evaluate Facial Harmony and Subject Satisfaction Using Restylane Defyne in a Stepwise Treatment Approach
- ClinicalTrials.gov ID
- NCT04520997
- Acronym / sponsor ID
- 05DF1910
- Conditions
- Lower Face Folds and Lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Posted 14 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down-up | Experimental | Device: Restylane DefyneParticipants in this group received up to 2 mL Restylane Defyne on chin at baseline and up to 2 mL of Restylane Defyne per NLF at baseline and up to 2 mL per ML of Restylane Defyne at Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. |
| Top-down | Experimental | Device: Restylane DefyneParticipants in this group received up to 2 mL Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at baseline and up to 2mL on chin Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects willed to comply with the requirements of the study and provided a signed written informed consent
- Subjects willed to undergo augmentation and correction therapy in the studied indications
- Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21
Key exclusion criteria (3 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
- Participation in any interventional clinical study within 30 days of screening
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 |
|---|---|---|
| Restylane DefyneUp to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6. | Device | Down-up |
| Restylane DefyneUp to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6. | Device | Top-down |
Primary outcome
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Time frame: At Week 3
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Time frame: At Week 6
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported.
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Time frame: At Week 9
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from "worse" to "very much improved" as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.
2 secondary outcomes
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Time frame: At Week 3, 6, and 9
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Time frame: At Week 3, 6 and 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Defyne in people with Lower Face Folds and Lines, run by Galderma R&D at 5 sites in 3 countries.
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 3 inclusion and 3 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Brazil, Italy. 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 14 Apr 2023). 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?
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 (time frame: At Week 3). 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 14 Apr 2023.