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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
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.
Galderma Research Site
Birmingham, Alabama, United States
Galderma Research Site
Chicago, Illinois, United States
Galderma Research Site
Belo Horizonte, Brazil
Galderma Research Site
São Paulo, Brazil
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Galderma Research Site
Palermo, Italy
Time frame: At Week 9
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.
Time frame: 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.
Time frame: At Week 3, 6 and 9