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Neuromodulator

Restylane Filler Line and Dysport Neuromodulator for Cosmetic

N/A
Recruiting
Led By Andreas Nikolis, MD
Research Sponsored by Erevna Innovations Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 2, week 4, week 8, week 20
Awards & highlights

Study Summary

This trial will test a new approach called "Kiss and Smile HIT" which focuses on improving lip appearance and smile by using specific treatments for different issues such as volume loss or lack of expression.

Who is the study for?
This trial is for individuals seeking cosmetic enhancements specifically for their lips and smile. Ideal candidates are those looking to address issues like volume loss, poorly defined lip contours, or expression-related concerns that affect confidence in their smile.Check my eligibility
What is being tested?
The trial tests the 'Kiss and Smile HIT' algorithm using Restylane fillers and Dysport neuromodulator. It aims to personalize treatment based on individual facial features, focusing on improving lip volume, framing, and expressive aspects of the smile.See study design
What are the potential side effects?
Potential side effects may include temporary swelling, bruising at injection sites, mild pain or discomfort. Rarely there might be allergic reactions or muscle weakness affecting nearby facial expressions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 2, week 4, week 8, week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 2, week 4, week 8, week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Global Aesthetic Improvement Scale (GAIS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Restylane Filler Line and Dysport NeuromodulatorExperimental Treatment1 Intervention
This study will consist of an open-label, prospective, cohort trial design. Twenty-four subjects will be recruited. Subjects will be recruited based on their primary deficit, 8 subjects will have a primary deficit in lip volume, 8 subjects will have a primary deficit in lip framing and 8 subjects will have a primary deficit in expression. All subjects will receive active treatment with hyaluronic acid at Baseline, with an optional touch at week two. There will be no placebo or no-treatment control groups. Subjects will be followed for five months.

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Who is running the clinical trial?

Erevna Innovations Inc.Lead Sponsor
12 Previous Clinical Trials
320 Total Patients Enrolled
Andreas Nikolis, MDPrincipal InvestigatorErevna Innovations Inc.
4 Previous Clinical Trials
140 Total Patients Enrolled

Frequently Asked Questions

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

Is the recruitment for this research study presently ongoing?

"Indeed, as indicated on clinicaltrials.gov, this particular medical investigation is currently seeking suitable candidates. Originally shared on November 2nd, 2023, with the latest revision made on March 22nd, 2024. The trial aims to recruit a total of 24 participants from one designated site."

Answered by AI

What is the total number of participants enrolled in this research investigation?

"Yes, information from clinicaltrials.gov confirms that this study is actively seeking participants. The trial was first listed on November 2nd, 2023 and last updated on March 22nd, 2024. Researchers aim to enroll a total of 24 subjects at one specific site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Kiss and Smile HIT
2023. "Kiss and Smile HIT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336785.
~12 spots leftby Nov 2024
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