NCT06385171 · Global Aesthetics LLC
Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
What this study is about
A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable.
View original scientific description
A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals of both genders.
- Must be in good physical health.
- Age between 20 and 65 years.
- Presence of both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region.
- Must possess the willingness and ability to understand and provide informed consent, as well as effectively communicate with study personnel.
Exclusion criteria
- Pregnant or breastfeeding female.
- Age below 20 or above 65 years.
- History of neuromuscular disorders, such as myasthenia gravis.
- History of facial surgery or presence of scars in the treatment area that could potentially interfere with or confound the results of the study.
- Recent treatment history within the past 6 months in the forehead or glabellar region, including:
- Ablative laser procedures.
- Radiofrequency device treatments.
- Ultrasound device treatments.
- Medium to deep chemical peels.
- Temporary soft tissue augmentation.
- Semi-permanent soft tissue augmentation within the past 2 years.
- Permanent soft tissue augmentation.
- Planned cosmetic procedures within the next 6 months in the same region.
- Intended use of tretinoin or retinoic acid within the next 6 months.
- Presence of active infection in the treated area, excluding mild acne.
- Allergy to cow's milk protein or albumin.
- Use of aminoglycoside medications.
- Current use of anticoagulation therapy.
- History of bleeding disorders.
- Diagnosis of mental illness.
- Inability to comprehend the study protocol or provide informed consent.
Where
- Cisco, Texas
- Lubbock, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 24, 2024 · Source of record for eligibility and locations