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 range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT04609020

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-10

Results submitted2025-05-02

View on ClinicalTrials.gov More Facial Rhytides trials