- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04520997
Restylane Defyne in a Stepwise Treatment Approach
April 13, 2023 updated by: Galderma R&D
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belo Horizonte, Brazil
- Galderma Research Site
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São Paulo, Brazil
- Galderma Research Site
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Palermo, Italy
- Galderma Research Site
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Alabama
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Birmingham, Alabama, United States, 35209
- Galderma Research Site
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Illinois
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Chicago, Illinois, United States, 60611
- Galderma Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Down-up
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.
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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.
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.
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Experimental: Top-down
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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At Week 3
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Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Time Frame: At Week 6
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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.
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At Week 6
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Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Time Frame: At Week 9
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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.
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At Week 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
Time Frame: At Week 3, 6, and 9
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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.
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At Week 3, 6, and 9
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Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Time Frame: At Week 3, 6 and 9
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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.
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At Week 3, 6 and 9
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2020
Primary Completion (Actual)
September 15, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05DF1910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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