Evaluating the effects of Botulinum Toxin Type A on facial wrinkles

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

This study is testing if Botulinum Toxin Type A can safely reduce facial wrinkles and improve satisfaction with the results for people from different backgrounds.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Global Aesthetics LLC (Academic / other)
• Locations: 2 sites (Cisco, Texas and 1 other locations)
• Trial ID: NCT06385171 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the efficacy and safety of Botulinum Toxin Type A in reducing facial wrinkles among a diverse population. The study will explore optimal dosages for significant cosmetic improvement while minimizing side effects, and it will evaluate patient satisfaction with the results. By employing a rigorous, controlled, and open-label methodology, the research seeks to make cosmetic treatments more accessible and affordable for individuals across various economic backgrounds. The findings will contribute valuable insights into cost-effective practices in cosmetic dermatology.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 20 to 65 with moderate dynamic and static wrinkles on the forehead or glabellar region.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of neuromuscular disorders or recent facial treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide patients with a safe and effective option for reducing facial wrinkles, enhancing their aesthetic appearance.

How similar studies have performed: Previous studies have shown positive outcomes with Botulinum Toxin Type A for wrinkle reduction, indicating that this approach is well-supported in the literature.

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.

Where this trial is running

Cisco, Texas and 1 other locations

• Global Aesthetics LLC — Cisco, Texas, United States (Recruiting)
• Global Aesthetics LLC — Lubbock, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Otis Scroggins, BS, CNA — Global Aesthetics LLC
• Study coordinator: Otis Scroggins, BS, CNA

Conditions Wrinkle; Facial Wrinkles