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Treatment Group for Injection Site Pain

Phase 4
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial compares the comfort of a pain-relief injection with no comfort intervention to see which is more effective.

Who is the study for?
Adults aged 18-65 with moderate-to-severe frown lines who have not had facial injections like Botox or fillers. Participants must be in good health, able to consent, and willing to follow study procedures. Pregnant women, smokers, those with certain allergies or skin conditions near the treatment area are excluded.Check my eligibility
What is being tested?
The trial is testing if using a Vibrating Beauty Bar during injection of Botulinum Toxin reduces pain compared to no comfort intervention. It's an open-label study where participants' experiences on both sides of their face are compared.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, mild bruising or swelling, headache, and rarely allergic reactions. The vibrating bar itself should not cause any significant side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analogue Scale
Secondary outcome measures
Self-assessment questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects will be treated for correction of glabellar lines with Dysport and comfort intervention on one side and Dysport only on the other side depending on pre-determined randomization. Subjects will complete the study assessments and end the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibrating Beauty Bar
2023
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,258 Total Patients Enrolled
DeNova ResearchOTHER
21 Previous Clinical Trials
1,347 Total Patients Enrolled

Frequently Asked Questions

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

Does this evaluation accept enrollees who have reached retirement age?

"Eligible participants for this clinical trial must be aged 18 or over yet younger than 64."

Answered by AI

Are there any available opportunities for patients to take part in this clinical trial?

"As specified on clinicaltrials.gov, this medical trial is currently in search of participants and was first posted on October 23rd 2023 with the latest update taking place November 30th 2023."

Answered by AI

Has Treatment Group received regulatory clearance from the FDA?

"This treatment has been approved, so its safety rating is a 3."

Answered by AI

How many participants have volunteered for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial which was initiated on October 23rd 2023 is still searching for participants. The research requires 60 individuals from 1 location to take part in the study."

Answered by AI

Who is eligible to take part in this research initiative?

"This research study seeks 60 participants, requiring they have injection site pain and are in the 18 to 64 age range."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
2023. "A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161246.
~40 spots leftby Apr 2025
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