Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
ConditionWrinkle
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-65
SponsorGlobal Aesthetics LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The population from which the groups or cohorts will be selected consists of individuals aged between 20 and 65 years, regardless of gender, who are seeking treatment for facial wrinkles. These individuals must be in good physical health and exhibit both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region. They should also possess the willingness and ability to understand and provide informed consent for participation in the study. This population may include individuals from various backgrounds and demographics who are interested in cosmetic dermatology procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Botulinum toxin type A
DrugThe 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Single Group Assignment1 intervention
Trial outcomes
Primary outcomes
1
Change 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 years2
Facial Appearance
Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.
Time frame
Upto 2 years3
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 yearsSecondary outcomes
1
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov