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

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.

Study Overview

• Status: Recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Drug: Botulinum toxin type A

Detailed Description

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 (Estimated): 500

Contacts and Locations

• Study Contact: Name: Otis Scroggins, BS, CNA; Phone Number: 8063707428; Email: fakefaceaesthetics@gmail.com

Study Locations

• United States
  • Texas
    • Cisco, Texas, United States, 76437
      • Recruiting
      • Global Aesthetics LLC
      • Contact: Otis Scroggins, BS, CNA; Phone Number: 806-370-7428; Email: fakefaceaesthetics@gmail.com
      • Principal Investigator: Otis Scroggins, BS, CNA
    • Lubbock, Texas, United States, 79413
      • Recruiting
      • Global Aesthetics LLC
      • Contact: Otis Scroggins, BS, CNA; Phone Number: 806-370-7428; Email: fakefaceaesthetics@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Group Assignment; Experimental: Botulinum Toxin Type A: Patients will receive their first treatment on Day 1 after screening, with baseline facial muscle assessment on Day 0. Touch-up treatments will be given every 3 weeks until the sixth month. At Week 3, primary efficacy assessment will be conducted by evaluating facial movement control. Longevity assessment will occur at Month 6, with additional evaluation of immune response. This cycle will repeat for the second dose after six months until one year, and the same cycle will repeat for the 2nd dose.

Drug: Botulinum 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.; Other Names: OnabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Upto 2 years
Facial Appearance	Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.	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.	Upto 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Upto 2 years

Collaborators and Investigators

• Sponsor: Global Aesthetics LLC
• Investigators: Principal Investigator: Otis Scroggins, BS, CNA, Global Aesthetics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 5, 2027

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Facial Wrinkles
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: FFA-BTX-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The reason for this decision is due to ongoing considerations regarding data privacy, ethical considerations, and the need for further consultation with relevant stakeholders, including participants and regulatory bodies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No