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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06385171
Recruitment Status : Not yet recruiting
First Posted : April 25, 2024
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Otis Reid Scroggins, Global Aesthetics LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Wrinkle 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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
Estimated Study Start Date : July 1, 2024
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : January 5, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Groups and Cohorts
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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 Name: OnabotulinumtoxinA


Outcome Measures
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Primary Outcome Measures :
  1. Change in facial wrinkles and Lines [ Time Frame: Upto 2 years ]

    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.


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

  3. Assessment of Wrinkle Severity [ Time Frame: Upto 2 years ]
    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.


Secondary Outcome Measures :
  1. Assessment of Skin Reaction [ Time Frame: Upto 2 years ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06385171


Contacts
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Contact: Otis Scroggins, BS, CNA 8063707428 fakefaceaesthetics@gmail.com

Locations
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United States, Texas
Global Aesthetics LLC
Cisco, Texas, United States, 76437
Global Aesthetics LLC
Lubbock, Texas, United States, 79413
Contact: Otis Scroggins, BS, CNA    806-370-7428    fakefaceaesthetics@gmail.com   
Sponsors and Collaborators
Global Aesthetics LLC
Investigators
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Principal Investigator: Otis Scroggins, BS, CNA Global Aesthetics LLC
More Information
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Responsible Party: Otis Reid Scroggins, Director, Principal Investigator, Clinical Aesthetician, Global Aesthetics LLC
ClinicalTrials.gov Identifier: NCT06385171    
Other Study ID Numbers: FFA-BTX-1
First Posted: April 25, 2024    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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
Keywords provided by Otis Reid Scroggins, Global Aesthetics LLC:
Facial Wrinkles
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents