Actively Recruiting
Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
Led by Global Aesthetics LLC · Updated on 2024-05-24
500
Participants Needed
2
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well Botulinum Toxin Type A works to reduce facial wrinkles and if it is safe for people aged 20 to 65 years. This study aims to find the best dose that improves the appearance of wrinkles with minimal side effects, while also making cosmetic treatments more affordable and accessible across different economic backgrounds. The research is conducted using a controlled, open-label approach to gather detailed information on treatment effects and patient satisfaction. Participants will receive an initial treatment of Botulinum Toxin Type A after screening and baseline facial muscle assessment. Touch-up treatments will be given every three weeks for six months, with assessments of facial movement control at three weeks and evaluation of wrinkle longevity and immune response at six months. This treatment cycle will repeat after six months for a second dose, continuing up to one year. During the study, participants will undergo regular evaluations to measure changes in facial wrinkles, wrinkle severity, and overall facial appearance for up to two years. Skin reactions will also be monitored throughout the study. Researchers will collect detailed records of dosages and treatment effects to understand the safety and cosmetic outcomes. The total participation time includes treatment and follow-up assessments to provide comprehensive long-term data.
CONDITIONS
Brief Title
Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of both genders
- Must be in good physical health
- Age between 20 and 65 years
- Presence of both static and moderate dynamic wrinkles on the forehead or glabellar region
- Willingness and ability to understand and provide informed consent and communicate with study personnel
You will not qualify if you...
- Pregnant or breastfeeding female
- Age below 20 or above 65 years
- History of neuromuscular disorders such as myasthenia gravis
- History of facial surgery or scars in the treatment area that may affect study results
- Recent treatments in the forehead or glabellar region within the past 6 months, including ablative laser, radiofrequency, ultrasound, medium to deep chemical peels, or temporary soft tissue augmentation
- Semi-permanent soft tissue augmentation within the past 2 years
- Permanent soft tissue augmentation
- Planned cosmetic procedures in the treatment area within the next 6 months
- Intended use of tretinoin or retinoic acid in the next 6 months
- Active infection in the treated area (excluding mild acne)
- Allergy to cow's milk protein or albumin
- Use of aminoglycoside medications
- Current anticoagulation therapy
- History of bleeding disorders
- Diagnosis of mental illness
- Inability to comprehend the study protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive Botulinum Toxin Type A injections to reduce facial wrinkles, with dosages tailored to individual needs. Baseline facial muscle assessment occurs before the first treatment. Touch-up treatments are administered every 3 weeks until six months, with efficacy and longevity assessments conducted during this period. This treatment cycle repeats after six months for a second dose.
Baseline visit, then touch-up visits every 3 weeks for 6 months per treatment cycle
Duration - Up to 2 years
Participants are monitored for long-term changes in facial wrinkles, immune response, and skin reactions up to two years to assess the lasting effects and safety of the treatment.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 2 locations
1
Global Aesthetics LLC
Cisco, Texas, United States, 76437
Actively Recruiting
2
Global Aesthetics LLC
Lubbock, Texas, United States, 79413
Actively Recruiting
Research Team
O
Otis Scroggins, BS, CNA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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