Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation

Launched by GLOBAL AESTHETICS LLC · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how well a treatment called Botulinum Toxin Type A can help reduce facial wrinkles. The goal is to see if this treatment is both safe and effective for making wrinkles on the forehead and between the eyebrows less noticeable. The study is currently looking for participants who are generally healthy, between the ages of 20 and 65, and have both static wrinkles (that don't change with movement) and moderate dynamic wrinkles (that appear with facial expressions).

If you decide to participate, you'll need to be able to understand the study and communicate with the research team. However, there are some important factors to consider before joining, such as not being pregnant or breastfeeding, having no recent facial surgeries, and not having certain medical conditions like neuromuscular disorders. Participants can expect to receive the treatment and be monitored for its effects. Overall, this trial aims to provide valuable information about how effective this wrinkle treatment may be.

Gender

ALL

Eligibility criteria

• 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.