Azzalure or Dysport
DrugGlabellar lines
Other names: Botulinum toxin
NCT Number: NCT02297516
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
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Notify Me35 year–50 year
All sexes
Interventional
Phase 4
Brazilian Center for Studies in Dermatology, Porto Alegre, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glabellar lines
Other names: Botulinum toxin
Facial tissue augmentation
Other names: Hyaluronic acid
Facial skin rejuvenation
Other names: Hyaluronic acid
Time frame: 7 months
Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1.
Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).
The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Time frame: 1, 7 and 13 months
Subjects showing superior "Global facial aesthetic appearance" at 1, 7 and 13 months.
Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).
The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?".
Time frame: 1, 7, and 13 months
The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?".
The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse.
Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved.
GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1).
Time frame: 7 and 13 months
The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is fulfilled for those subjects that answered ""Very/somewhat satisfied".
Time frame: 7 and 13 months
The Investigators answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria met for those subjects that the Investigator answered "Very/somewhat satisfied".
Time frame: 7 and 13 months
The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator.
A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs.
0 = No glabella lines
Time frame: Baseline
Evaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline).
Galderma R&D
Industry
An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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