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.
The primary purpose of this clinical trial is to evaluate the efficacy and safety of Botulinum Toxin Type A in the treatment of facial wrinkles among a diverse population, with a specific aim to bridge the gap between cosmetic injectables and varying financial statuses of potential patients. This study intends to determine the degree to which Botulinum Toxin Type A can reduce the appearance of facial wrinkles, identify the optimal dosage for significant cosmetic improvement with minimal side effects, and assess patient satisfaction with the outcomes. By conducting a rigorous, controlled, and open label methodology, this research aspires not only to provide comprehensive data supporting the use of Botulinum Toxin Type A as a safe and effective treatment for aesthetic improvement but also to make such treatments more accessible and affordable. This endeavor seeks to democratize cosmetic enhancements, ensuring that individuals across different economic backgrounds can benefit from advancements in cosmetic dermatology. Ultimately, the study aims to offer valuable insights into cost-effective practices without compromising treatment quality, thereby enhancing patient care practices and contributing significantly to the field of cosmetic dermatology.
Study Type
OBSERVATIONAL
Enrollment
500
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.
Global Aesthetics LLC
Cisco, Texas, United States
RECRUITINGGlobal Aesthetics LLC
Lubbock, Texas, United States
RECRUITINGChange in facial wrinkles and Lines
Visual Assessment: The Principal Investigator (PI) will visually assess the change in wrinkles and lines on the patient's face compared to baseline, using the following grading scale: Grade 0: No improvement in wrinkles. Grade 1: Minimal improvement, slight reduction in wrinkles. Grade 2: Moderate improvement, noticeable reduction in wrinkles. Grade 3: Significant improvement, substantial reduction in wrinkles. Assessment of Change in Wrinkles and Lines: Photographic Documentation: Before and after photographs will be taken to objectively compare the appearance of facial wrinkles and lines. The improvement will be graded using the following scale: Grade 0: No change or worsening of wrinkles. Grade 1: Slight improvement, minimal reduction in wrinkles. Grade 2: Moderate improvement, visible reduction in wrinkles. Grade 3: Significant improvement, marked reduction in wrinkles.
Time frame: Upto 2 years
Facial Appearance
Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.
Time frame: Upto 2 years
Assessment of Wrinkle Severity
The WSRS will rate the severity of wrinkles on a scale of 1 to 5, with 1 indicating no wrinkles and 5 indicating severe wrinkles.
Time frame: Upto 2 years
Assessment of Skin Reaction
The Principal Investigator (PI) will measure the presence and severity of skin reactions using a grading scale, where: Grade 0 represents no skin reaction, Grade 1 represents mild redness or inflammation, Grade 2 represents moderate redness or inflammation, and Grade 3 represents severe redness, inflammation, or swelling. By assigning a numerical value to skin reactions, the PI will quantify the degree of immune response, allowing for measurable comparisons over time.
Time frame: Upto 2 years
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