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Neurotoxin

BOTOX for Wrinkles

Phase 4

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe Glabellar Lines, Lateral Canthal Lines, and Forehead Lines

Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

Study Summary

This trial is studying the satisfaction and results of using BOTOX Cosmetic to treat facial lines such as glabellar lines, lateral canthal lines, and forehead lines. About 100 adult participants with

Who is the study for?

This trial is for adults with moderate to severe upper facial lines, including frown lines between the eyebrows (glabellar), crow's feet (lateral canthal), and forehead wrinkles. Participants must be able to assess their wrinkles without glasses, though contacts are fine.Check my eligibility

What is being tested?

The study tests participant satisfaction with BOTOX Cosmetic injections for treating upper facial lines. It's an open-label study where around 100 participants at various sites in the US and Canada will receive BOTOX injections and attend regular check-ups.See study design

What are the potential side effects?

Possible side effects of BOTOX may include pain at the injection site, headache, flu-like symptoms, droopy eyelids or eyebrows, eye dryness or excessive tearing. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe frown, crow's feet, and forehead lines.

Select...

I can see well enough without glasses to notice wrinkles on my face.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Responder Status of 'Mostly satisfied' or 'Very satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction with the Natural Look)

Secondary outcome measures

Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function

Trial Design

1Treatment groups

Experimental Treatment

Group I: BOTOXExperimental Treatment1 Intervention

Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2013

Completed Phase 4

~1200

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,290 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,009 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this study at the moment?

"The search on clinicaltrials.gov shows this investigation actively seeks participants. It was initially listed on 2nd May 2024 and last modified on the following day, 3rd February 2024."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, information from clinicaltrials.gov indicates that this investigation is actively seeking participants. The trial was posted for the first time on February 5th, 2024, and its most recent update was on February 6th of the same year. This study aims to recruit a total of 100 patients across one site."

Answered by AI

What are the potential risks associated with BOTOX treatment for individuals?

"Our evaluation at Power indicates that the safety rating for BOTOX is a 3, reflecting its approval status in this Phase 4 trial."

Answered by AI

Who else is applying?

What site did they apply to?

Tennessee Clinical Research Center /ID# 259161

Integrated Aesthetics - Spring /ID# 257738

Bertucci MedSpa Inc. /ID# 249757

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

I want to look younger. I would love to feel better about myself after spinal injury I used to get injectables but now can’t afford and I truly miss it not to mention I have more wrinkles.now.

PatientReceived 1 prior treatment

Over the last 3 years I have noticed a significant increase in the lines on my face. I have tried small amounts of Botox a few years ago, but it is cost prohibitive for me to really get the amount that I need to fix my crows feet and the rest of my face. I truly believe that medical research plays a vital role in the pharmaceutical industry and would like to contribute. If I can get botox through a clinical study then that is a win / win in my book.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

2024. "A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218251.

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