Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treat… (NCT04609020) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment
Brazil64 participantsStarted 2023-02-15
Plain-language summary
The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of the Sponsor's products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit
Who can participate
Age range35 Years – 65 Years
SexALL
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Inclusion Criteria:
* Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study
* Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study
* Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study
* Must qualify to receive BOTOX treatments, in at least one area, as per the approved Product Monograph including treatment of hyperkinetic lines for the glabellar, crow's feet, and forehead lines:
* Glabellar injection: glabellar rhytides characterized as moderate or severe during maximum muscle contraction on the evaluation of the facial wrinkle scale (FWS)
* CFLs characterized as 2 (moderate) or 3 (severe) during maximum smile on the evaluation of the FWS
* Forehead lines (FHLs) of moderate to 3 severe rating at maximum eyebrow elevation as assessed using the FWS
Exclusion Criteria:
* Body mass index (BMI) \> 30 kg/m2
* Known allergy or sensitivity to the study products or their components
* Pregnant, lactating, or planning to become pregnant at any time during the study
* Received BOTOX or treatment with any other botulinum toxin product for any condition within 6 months before enrollment
* Received (or is planning to receive) anti-coagulation, antiplatelet or thrombolytic medications (e.g., warfa…
What they're measuring
1
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
Timeframe: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)