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

NCT06385171 | Recruiting DMC FDA Drug

• 1 other identifier: FFA-BTX-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Wrinkle

Keywords

Facial Wrinkles

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessment of Skin Reaction

  Upto 2 years

Study Arms (1)

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

Interventions

Botulinum toxin type A DRUG

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.

Also known as: OnabotulinumtoxinA

Single Group Assignment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Aesthetics LLC: lead

Study Sites (2)

Global Aesthetics LLC

Cisco, Texas, 76437, United States

RECRUITING

Global Aesthetics LLC

Lubbock, Texas, 79413, United States

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Otis Scroggins, BS, CNA

  Global Aesthetics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otis Scroggins, BS, CNA

CONTACT

8063707428; fakefaceaesthetics@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Aesthetician

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 25, 2024
• Study Start: May 22, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): January 5, 2027
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (2)