Wrinkle Clinical Trial
Official title:
Head-to-Head Comparison of the Efficacy and Safety of All Five Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Triple-Blind, Randomized Controlled Trial
Study Type: This is a multicenter, triple-blind, randomized controlled trial. Purpose: The goal of this clinical trial is to compare the effectiveness and safety of all five commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects. Main Questions the Study Aims to Answer: Which BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects? Participant Tasks: Women aged 18 years or older with moderate to severe glabellar lines will participate. Participants will receive injections of a BoNT-A product into specific facial muscles. They will need to take weekly photographs using their smartphones to document changes in their frown lines. These photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition. Comparison Group: Researchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time. The safety profiles of these products will also be compared to determine which has the fewest and least severe side effects. This study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.
Background: Glabellar rhytides, commonly known as frown lines, are a significant aesthetic concern for many individuals, leading to increasing utilization of Botulinum Neurotoxin Type A (BoNT-A) treatments. Despite multiple products being available, comprehensive comparative data on their efficacy and safety are limited. This trial aims to fill this evidence gap by evaluating and comparing the effectiveness and safety profiles of all five FDA-approved BoNT-A products. Methods: Conducted across several clinical sites, this multicenter, triple-blind, randomized controlled trial will involve a structured intervention where participants receive one of five different BoNT-A formulations. The study employs a stringent blinding and randomization process to ensure the objectivity and reliability of the results. Data on treatment efficacy, safety, and participant-reported outcomes will be collected at baseline and follow-up through direct clinical assessments and secure digital communication methods. Data Collection and Analysis: Data collection will include baseline and 16-week follow-up assessments using standardized clinical scales and self-reported question anaires. Participants will document 30 weekly progress through standardized 'selfie' photos using a secure, encrypted application to ensure data privacy. The primary outcome, the duration of treatment efficacy, will be analyzed using Kaplan-Meier survival analysis. Secondary outcomes, including the incidence of adverse events and participant satisfaction, will be analyzed using repeated measures ANOVA and logistic regression. Detailed duration of effect will be assessed using Kaplan-Meier curves and Cox proportional hazards models. Statistical Analysis: The study is powered to detect meaningful clinical differences between the treatment groups with a high degree of statistical confidence. The analysis will explore treatment effects over time and assess factors influencing treatment efficacy and safety. Conclusion: By rigorously comparing all available BoNT-A products, this study will provide critical insights into their relative effectiveness and safety, significantly informing clinical decision-making and optimizing patient care strategies for treating glabellar lines. The findings are expected to enhance the understanding of treatment dynamics and guide future therapeutic approaches in aesthetic medicine. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05098912 -
Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction
|
N/A | |
Completed |
NCT05271136 -
A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
|
N/A | |
Completed |
NCT05096247 -
Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
|
N/A | |
Completed |
NCT05097157 -
Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
|
N/A | |
Completed |
NCT04128046 -
The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation
|
N/A | |
Active, not recruiting |
NCT04727099 -
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
|
N/A | |
Active, not recruiting |
NCT06140628 -
A 28-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
Not yet recruiting |
NCT05524779 -
BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement
|
N/A | |
Completed |
NCT05514782 -
A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
|
N/A | |
Completed |
NCT06123572 -
A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
|
N/A | |
Completed |
NCT04911374 -
An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream
|
N/A | |
Recruiting |
NCT04989361 -
Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles.
|
N/A | |
Recruiting |
NCT04540900 -
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
|
Phase 1 | |
Recruiting |
NCT06202274 -
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
|
N/A | |
Recruiting |
NCT06074276 -
The Effects of Almond on Facial Skin Collagen and Wrinkles
|
N/A | |
Completed |
NCT06366503 -
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
|
N/A | |
Active, not recruiting |
NCT06219278 -
A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
|
N/A | |
Active, not recruiting |
NCT06192550 -
Functional Usability and Feasibility Testing of the Profound Matrix™ System
|
N/A | |
Completed |
NCT04650620 -
Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
|
N/A | |
Completed |
NCT03729700 -
The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome
|
N/A |