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Procedure

Botox for Scar Improvement Post-Brow Lift

N/A

Waitlist Available

Led By Ahsen Hussain, FRCOphth, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

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

Must have

Participants must be over 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 12 months

Awards & highlights

Study Summary

This trial is looking at whether injecting botulinum toxin immediately after a direct brow lift can improve the appearance of scars.

Who is the study for?

This trial is for patients undergoing bilateral direct brow lifts at Victoria General Hospital in Halifax, Nova Scotia. It's designed to see if onabotulinum toxin A can improve scarring outcomes after surgery.Check my eligibility

What is being tested?

The study tests whether injecting onabotulinum toxin A (Botox) right after a direct brow lift surgery leads to better scar healing compared to no treatment. This double-masked trial randomly assigns participants to receive either Botox or a placebo.See study design

What are the potential side effects?

Potential side effects of Botox may include pain at the injection site, headache, temporary eyelid drooping, and less commonly muscle weakness where injected.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Degree of brow lift achieved

Effect of onabotulinum toxin A on scarring in direct brow lift surgery

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: onabotulinum toxin A group (brow)Experimental Treatment1 Intervention

Product name: Onabotulinum toxin A (Botox A, Allergan), 50 unit vials Product code: 93094EC Description: The side randomized to treatment will receive an injection of 20 units of onabotulinum toxin A as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration.

Group II: placebo group (brow)Placebo Group1 Intervention

Product name: normal saline Description: The side randomized to placebo will receive an injection of normal saline as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botox Injectable Product

2019

Completed Phase 4

~200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dalhousie UniversityOTHER

167 Previous Clinical Trials

403,122 Total Patients Enrolled

Nova Scotia Health AuthorityLead Sponsor

258 Previous Clinical Trials

83,838 Total Patients Enrolled

Dalhousie Ophthalmology and Visual Sciences Research GroupUNKNOWN

Media Library

Onabotulinum Toxin A (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04383912 — N/A

Direct Brow Lift Research Study Groups: onabotulinum toxin A group (brow), placebo group (brow)

Direct Brow Lift Clinical Trial 2023: Onabotulinum Toxin A Highlights & Side Effects. Trial Name: NCT04383912 — N/A

Onabotulinum Toxin A (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04383912 — N/A

Frequently Asked Questions

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

What common ailments is Botox Injectable Product employed to alleviate?

"Botox Injectable Product is commonly used to reduce the symptoms of urinary incontinence, and may also prove beneficial in managing spinal cord diseases, botox, and overactive bladder syndrome (OABs)."

Answered by AI

Is the sign-up process open to new participants?

"Indeed, clinicaltrials.gov suggests that this research protocol is currently recruiting participants with the first postdating back to November 18th 2020 and its latest update being on July 21st 2022. A total of 16 patients need to be recruited from a single trial site."

Answered by AI

What is the current scope of this clinical investigation?

"Affirmative. Information posted on clinicaltrials.gov shows that this medical investigation, which became available for enrollment on November 18th 2020 is currently looking to recruit 16 people at a single location."

Answered by AI

Have any other investigations been conducted on the effectiveness of Botox Injectable Product?

"At present, 61 clinical trials are being conducted to assess the efficacy of Botox Injectable Product with 20 already in Phase 3. Though a few studies for this product is occurring in Farmington Hills, Michigan, there are 759 sites situated around the world running related experiments."

Answered by AI

Recent research and studies

Lasers in Surgery and MedicineJournal

Split Face Evaluation of Long-pulsed Non-ablative 1,064 Nm Nd:yag Laser for Treatment of Direct Browplasty Scars

Tenzel, Phillip A., Karan Patel, Benjamin P. Erickson, Erin M. Shriver, Lisa D. Grunebaum, Chrisfouad R. Alabiad, Wendy W. Lee, and Sara T. Wester. 2016. “Split Face Evaluation of Long-pulsed Non-ablative 1,064 Nm Nd:yag Laser for Treatment of Direct Browplasty Scars”. Lasers in Surgery and Medicine. Wiley. doi:10.1002/lsm.22543.

Plastic and Reconstructive Surgery - Global OpenJournal

Complications in Brow Lifts

Cho, Min-Jeong, Jourdan A. Carboy, and Rod J. Rohrich. 2018. “Complications in Brow Lifts”. Plastic and Reconstructive Surgery - Global Open. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/gox.0000000000001943.

British Journal of OphthalmologyJournal

The Direct Brow Lift: Efficacy, Complications, and Patient Satisfaction

Booth, A J. 2004. “The Direct Brow Lift: Efficacy, Complications, and Patient Satisfaction”. British Journal of Ophthalmology. BMJ. doi:10.1136/bjo.2003.019232.

Canadian Journal of OphthalmologyJournal