RecruitingNCT06385171

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

Sponsor

Global Aesthetics LLC

Enrollment

500 participants

Start Date

May 22, 2024

Study Type

OBSERVATIONAL

Conditions

Wrinkle

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria21

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBotulinum toxin type A

The intervention involves the administration of Botulinum Toxin Type A, with dosages regulated according to FDA guidelines. Each injection site will receive a maximum of 4 units, adhering to the FDA's recommended dosage limits. Dosages administered will be tailored to each patient's needs and will be recorded in their individual patient information chart.